ABSTRACT

Instability of the proximal tibiofibular joint (PTFJ) is a rare clinical condition that presents unique challenges to treatment. We present the case of an active 26-year-old woman with a 4-year history of recurrent PTFJ subluxations, treated surgically at our institution using a split biceps femoris tendon graft for PTFJ reconstruction. She underwent several attempts at nonoperative management until we decided to proceed with surgical intervention. A split biceps femoris graft was used to restore stability of the PTFJ. Approximately 5 years postoperatively, she achieved full range of motion as well as functional and clinical Knee Society Scores of 94 and 90 points, respectively. To the best of our knowledge, this is the first case report of PTFJ instability treated surgically with long-term follow-up. Future studies should focus on the long-term satisfactory outcomes of soft tissue stabilization of a chronically unstable PTFJ.

The instability of the proximal tibiofibular joint (PTFJ) is a rare clinical condition that commonly occurs secondary to an initial pivoting or twisting event of a flexed knee. Although acute PTFJ dislocations respond well to closed reduction and casting, the treatment of chronic PTFJ instability presents a unique challenge.¹ Surgical fixation methods include tibiofibular joint recreation using either a split semitendinosus or biceps femoris graft, as well as a Tightrope device.^2-6 Older surgical options for chronic PTFJ instability include fibular head resection or PTFJ arthrodesis.⁷ However, these older techniques have fallen out of favor, and the optimal surgical technique for the treatment of this injury remains a point of contention.

We present the case of an active 26-year-old woman with a 4-year history of recurrent PTFJ subluxations. The patient was surgically treated at our institution by using a split biceps femoris tendon graft for PTFJ reconstruction. This article specifically details the surgical technique used, provides data obtained at the 5-year clinical follow-up, and reviews prior publications on this injury. The patient provided written informed consent for print and electronic publication of this case report.

CASE

A 26-year-old woman presented with a 4-year history of lateral right knee pain with any physical activity. She stated that her pain began immediately following a fall, which was initially treated with casting and immobilization for approximately 6 weeks. After treatment, she began to develop symptoms of “popping on the outside of the knee.” In the 8 months prior to her presentation to our practice, these symptoms had intensified in pain severity and frequency. She reported that the popping events occurred most often with deep squatting.

No gross deformity was observed upon physical examination, and both knees were visibly symmetric. Evidence of effusion was absent. The patient felt no pain with the passive motion of her knee, and she presented the full range of motion (ROM) from 0° to 120°. Anterior drawer, McMurray, Lachman, and pivot shift tests were all negative. Upon the application of manual pressure, the fibular head could be dislocated anteriorly (Video 1). This dislocation recreated the patient’s symptoms. The fibular head could not be subluxed or dislocated posteriorly. Flexing the knee to 90° facilitated reproducing manual anterior dislocation. The contralateral knee was examined and demonstrated no appreciable PTFJ instability. The patient exhibited no other signs of generalized ligamentous laxity. Her sensation in the lower leg was intact, and she reported no tingling or numbness in the peroneal nerve distribution. Tinel’s test of the peroneal nerve was negative.

Continue to: X-ray imaging revealed...

When the patient presented to our office, she reported having undergone several failed efforts of nonoperative treatment, including bracing and activity modification. On the basis of the chronicity of the reported symptoms, level of pain, and the desire of the patient to return to full activity, we recommended the surgical reconstruction of the PTFJ by using a split biceps femoris tendon graft.

OPERATIVE TECHNIQUE

The patient was positioned supine on a Jackson table. General anesthesia was utilized. Biplanar fluoroscopic imaging of the fibula was obtained with the fibular head manually dislocated and reduced. A bump was placed beneath the right thigh to create resting knee flexion. The patient was prepped and draped in sterile fashion, and a tourniquet was applied.

A 10-cm curvilinear surgical incision was made centered over the fibular neck and extending proximally within the interval between the iliotibial band and the biceps femoris tendon. Dissection was performed. The peroneal nerve was identified, carefully dissected out, and then isolated with a vessel loop. The biceps femoris tendon insertion on the fibular head was dissected while ensuring that the nerve was isolated, and the anterior half of the tendon was marked approximately 14 cm proximally using a surgical marker. A 15-blade was then used to split the tendon proximally along the marked path while taking care to preserve the tendinous insertion on the fibular head. The split portion of the tendon was freed from all underlying tissue, and the most distal 2 cm was tubularized using a running baseball stitch and No. 2 Ethibond.

The anterior and posterior aspects of the fibular head were then débrided of tissue, and a guidewire was placed anteriorly-to-posterior. After the position of the guidewire was confirmed with fluoroscopy, a 5-0 cannulated reamer was used to drill through the fibular head. Next, the interval between the biceps femoris and iliotibial band was found, and the lateral head of the gastrocnemius was retracted posteriorly within this interval. A portion of the soleus muscle was also elevated off of the posterior capsule and posterior tibia. The iliotibial band insertion at Gerdy’s tubercle was then identified, and a guidewire was placed from anterior-to-posterior within the tibia, with the starting point just posterior to Gerdy’s tubercle. The wire was advanced under direct visualization with an ACL tibial guide and confirmed fluoroscopically. A 5-mm cannulated reamer was then used to drill over the guidewire through the anterior and posterior cortex of the tibia. A suture passer was passed anterior-to-posterior through this tunnel to retrieve the tubularized portion of the biceps femoris graft, which was then shuttled through the tibial tunnel. This same tubularized graft segment was then shuttled anteriorly-to-posteriorly through the fibular tunnel. At this point, approximately 3 cm of the graft protruded from the posterior aspect of the fibular tunnel.

Continue to: The remaining graft was held...

POSTOPERATIVE COURSE

The patient was initially kept in a knee immobilizer following surgery and instructed to use touch-down weight-bearing for 3 weeks. She was switched to a hinged brace at 1 week postoperatively. Physical therapy began with range of motion exercises, and an active flexion was withheld until 6 weeks postoperatively. After 6 weeks, the patient was allowed to progress to an active ROM and increase to weight-bearing as tolerated.  Strengthening was started at 12 weeks.

MRI was performed at 4 months postoperatively because the patient reported pain with running. The MRI demonstrated no evidence of stress reaction or fracture in the area of reconstruction. She was advised to continue with physical therapy and stop running. At 5-month post-reconstruction, the patient reported that her pain had resolved and that she had no complaints of any peroneal nerve neuropraxia. At 6 months she had returned to normal activity without complaints. At this point, she was instructed to follow-up as needed.

The patient was seen in office 5.5 years after the initial surgery for an unrelated orthopedic issue. At this time, follow-up data were obtained for her PTFJ reconstruction. She stated that she was very satisfied with the results of her surgery. She claimed to be pain free and had been performing normal activities without any difficulty. Upon physical examination, she achieved full range of motion.  She had no extension lag or flexion contracture. She achieved functional and clinical Knee Society Scores of 94 and 90 points, respectively.

DISCUSSION

This article details a soft tissue PTFJ reconstruction using a split biceps femoris graft with over 5 years of clinical follow-up. Chronic PTFJ instability is a rare clinical entity, and unless gross instability is evident upon physical examination, its diagnosis may be confused with the diagnosis of more common complaints, such as meniscal tears or iliotibial band syndrome.

Continue to: Ogden first described...

Past instances of PTFJ instability have been managed with closed reduction and protected weight-bearing, as well as with various open reduction techniques.^2-7 Surgical reconstruction is commonly considered in chronic cases or if nonoperative modalities have failed. Although PTFJ arthrodesis or fibular head resection has been used as a prior treatment option, the postoperative complications associated with each of these techniques have since caused them to fall out of favor.

The split biceps femoris graft has been successfully used in the soft tissue reconstruction of PTFJ.^3,5-7 The soft tissue reconstruction of the PTFJ provides advantages over arthrodesis or fibular head resection because it preserves normal anatomy and avoids secondary stresses to the ankle encountered in the latter procedure. Fibular head resection also presents secondary complications, such as the loss of the biceps femoris and posterolateral corner ligament insertion points.⁹ Similar to this study, prior works have reported returns to functionality. However, this study represents the longest clinical postoperative follow-up of PTFJ ligament reconstruction. By using a split biceps graft, the insertion point of the biceps on the fibular head is preserved, thus maintaining normal function while still allowing for an easily tubularized graft for anatomic PTFJ ligament reconstruction.

CONSLUSION

We present data for over 5 years of follow-up for our surgical approach to this rare pathology. To the best of our knowledge, this is the first case report of PTFJ instability that was treated surgically and with a long-term follow-up. The patient did not demonstrate loss of knee motion, pain, or peroneal nerve symptoms. Moreover, she was very satisfied with the procedure at the most recent follow-up and had returned to unrestricted activity. The soft tissue stabilization of a chronically unstable PTFJ is a viable treatment modality that provides good results, and future studies should confirm these satisfactory outcomes in the long-term.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Instability of the proximal tibiofibular joint (PTFJ) is a rare clinical condition that presents unique challenges to treatment. We present the case of an active 26-year-old woman with a 4-year history of recurrent PTFJ subluxations, treated surgically at our institution using a split biceps femoris tendon graft for PTFJ reconstruction. She underwent several attempts at nonoperative management until we decided to proceed with surgical intervention. A split biceps femoris graft was used to restore stability of the PTFJ. Approximately 5 years postoperatively, she achieved full range of motion as well as functional and clinical Knee Society Scores of 94 and 90 points, respectively. To the best of our knowledge, this is the first case report of PTFJ instability treated surgically with long-term follow-up. Future studies should focus on the long-term satisfactory outcomes of soft tissue stabilization of a chronically unstable PTFJ.

The instability of the proximal tibiofibular joint (PTFJ) is a rare clinical condition that commonly occurs secondary to an initial pivoting or twisting event of a flexed knee. Although acute PTFJ dislocations respond well to closed reduction and casting, the treatment of chronic PTFJ instability presents a unique challenge.¹ Surgical fixation methods include tibiofibular joint recreation using either a split semitendinosus or biceps femoris graft, as well as a Tightrope device.^2-6 Older surgical options for chronic PTFJ instability include fibular head resection or PTFJ arthrodesis.⁷ However, these older techniques have fallen out of favor, and the optimal surgical technique for the treatment of this injury remains a point of contention.

We present the case of an active 26-year-old woman with a 4-year history of recurrent PTFJ subluxations. The patient was surgically treated at our institution by using a split biceps femoris tendon graft for PTFJ reconstruction. This article specifically details the surgical technique used, provides data obtained at the 5-year clinical follow-up, and reviews prior publications on this injury. The patient provided written informed consent for print and electronic publication of this case report.

CASE

A 26-year-old woman presented with a 4-year history of lateral right knee pain with any physical activity. She stated that her pain began immediately following a fall, which was initially treated with casting and immobilization for approximately 6 weeks. After treatment, she began to develop symptoms of “popping on the outside of the knee.” In the 8 months prior to her presentation to our practice, these symptoms had intensified in pain severity and frequency. She reported that the popping events occurred most often with deep squatting.

No gross deformity was observed upon physical examination, and both knees were visibly symmetric. Evidence of effusion was absent. The patient felt no pain with the passive motion of her knee, and she presented the full range of motion (ROM) from 0° to 120°. Anterior drawer, McMurray, Lachman, and pivot shift tests were all negative. Upon the application of manual pressure, the fibular head could be dislocated anteriorly (Video 1). This dislocation recreated the patient’s symptoms. The fibular head could not be subluxed or dislocated posteriorly. Flexing the knee to 90° facilitated reproducing manual anterior dislocation. The contralateral knee was examined and demonstrated no appreciable PTFJ instability. The patient exhibited no other signs of generalized ligamentous laxity. Her sensation in the lower leg was intact, and she reported no tingling or numbness in the peroneal nerve distribution. Tinel’s test of the peroneal nerve was negative.

Continue to: X-ray imaging revealed...

When the patient presented to our office, she reported having undergone several failed efforts of nonoperative treatment, including bracing and activity modification. On the basis of the chronicity of the reported symptoms, level of pain, and the desire of the patient to return to full activity, we recommended the surgical reconstruction of the PTFJ by using a split biceps femoris tendon graft.

OPERATIVE TECHNIQUE

The patient was positioned supine on a Jackson table. General anesthesia was utilized. Biplanar fluoroscopic imaging of the fibula was obtained with the fibular head manually dislocated and reduced. A bump was placed beneath the right thigh to create resting knee flexion. The patient was prepped and draped in sterile fashion, and a tourniquet was applied.

A 10-cm curvilinear surgical incision was made centered over the fibular neck and extending proximally within the interval between the iliotibial band and the biceps femoris tendon. Dissection was performed. The peroneal nerve was identified, carefully dissected out, and then isolated with a vessel loop. The biceps femoris tendon insertion on the fibular head was dissected while ensuring that the nerve was isolated, and the anterior half of the tendon was marked approximately 14 cm proximally using a surgical marker. A 15-blade was then used to split the tendon proximally along the marked path while taking care to preserve the tendinous insertion on the fibular head. The split portion of the tendon was freed from all underlying tissue, and the most distal 2 cm was tubularized using a running baseball stitch and No. 2 Ethibond.

The anterior and posterior aspects of the fibular head were then débrided of tissue, and a guidewire was placed anteriorly-to-posterior. After the position of the guidewire was confirmed with fluoroscopy, a 5-0 cannulated reamer was used to drill through the fibular head. Next, the interval between the biceps femoris and iliotibial band was found, and the lateral head of the gastrocnemius was retracted posteriorly within this interval. A portion of the soleus muscle was also elevated off of the posterior capsule and posterior tibia. The iliotibial band insertion at Gerdy’s tubercle was then identified, and a guidewire was placed from anterior-to-posterior within the tibia, with the starting point just posterior to Gerdy’s tubercle. The wire was advanced under direct visualization with an ACL tibial guide and confirmed fluoroscopically. A 5-mm cannulated reamer was then used to drill over the guidewire through the anterior and posterior cortex of the tibia. A suture passer was passed anterior-to-posterior through this tunnel to retrieve the tubularized portion of the biceps femoris graft, which was then shuttled through the tibial tunnel. This same tubularized graft segment was then shuttled anteriorly-to-posteriorly through the fibular tunnel. At this point, approximately 3 cm of the graft protruded from the posterior aspect of the fibular tunnel.

Continue to: The remaining graft was held...

POSTOPERATIVE COURSE

The patient was initially kept in a knee immobilizer following surgery and instructed to use touch-down weight-bearing for 3 weeks. She was switched to a hinged brace at 1 week postoperatively. Physical therapy began with range of motion exercises, and an active flexion was withheld until 6 weeks postoperatively. After 6 weeks, the patient was allowed to progress to an active ROM and increase to weight-bearing as tolerated.  Strengthening was started at 12 weeks.

MRI was performed at 4 months postoperatively because the patient reported pain with running. The MRI demonstrated no evidence of stress reaction or fracture in the area of reconstruction. She was advised to continue with physical therapy and stop running. At 5-month post-reconstruction, the patient reported that her pain had resolved and that she had no complaints of any peroneal nerve neuropraxia. At 6 months she had returned to normal activity without complaints. At this point, she was instructed to follow-up as needed.

The patient was seen in office 5.5 years after the initial surgery for an unrelated orthopedic issue. At this time, follow-up data were obtained for her PTFJ reconstruction. She stated that she was very satisfied with the results of her surgery. She claimed to be pain free and had been performing normal activities without any difficulty. Upon physical examination, she achieved full range of motion.  She had no extension lag or flexion contracture. She achieved functional and clinical Knee Society Scores of 94 and 90 points, respectively.

DISCUSSION

This article details a soft tissue PTFJ reconstruction using a split biceps femoris graft with over 5 years of clinical follow-up. Chronic PTFJ instability is a rare clinical entity, and unless gross instability is evident upon physical examination, its diagnosis may be confused with the diagnosis of more common complaints, such as meniscal tears or iliotibial band syndrome.

Continue to: Ogden first described...

Past instances of PTFJ instability have been managed with closed reduction and protected weight-bearing, as well as with various open reduction techniques.^2-7 Surgical reconstruction is commonly considered in chronic cases or if nonoperative modalities have failed. Although PTFJ arthrodesis or fibular head resection has been used as a prior treatment option, the postoperative complications associated with each of these techniques have since caused them to fall out of favor.

The split biceps femoris graft has been successfully used in the soft tissue reconstruction of PTFJ.^3,5-7 The soft tissue reconstruction of the PTFJ provides advantages over arthrodesis or fibular head resection because it preserves normal anatomy and avoids secondary stresses to the ankle encountered in the latter procedure. Fibular head resection also presents secondary complications, such as the loss of the biceps femoris and posterolateral corner ligament insertion points.⁹ Similar to this study, prior works have reported returns to functionality. However, this study represents the longest clinical postoperative follow-up of PTFJ ligament reconstruction. By using a split biceps graft, the insertion point of the biceps on the fibular head is preserved, thus maintaining normal function while still allowing for an easily tubularized graft for anatomic PTFJ ligament reconstruction.

CONSLUSION

We present data for over 5 years of follow-up for our surgical approach to this rare pathology. To the best of our knowledge, this is the first case report of PTFJ instability that was treated surgically and with a long-term follow-up. The patient did not demonstrate loss of knee motion, pain, or peroneal nerve symptoms. Moreover, she was very satisfied with the procedure at the most recent follow-up and had returned to unrestricted activity. The soft tissue stabilization of a chronically unstable PTFJ is a viable treatment modality that provides good results, and future studies should confirm these satisfactory outcomes in the long-term.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Instability of the proximal tibiofibular joint (PTFJ) is a rare clinical condition that presents unique challenges to treatment. We present the case of an active 26-year-old woman with a 4-year history of recurrent PTFJ subluxations, treated surgically at our institution using a split biceps femoris tendon graft for PTFJ reconstruction. She underwent several attempts at nonoperative management until we decided to proceed with surgical intervention. A split biceps femoris graft was used to restore stability of the PTFJ. Approximately 5 years postoperatively, she achieved full range of motion as well as functional and clinical Knee Society Scores of 94 and 90 points, respectively. To the best of our knowledge, this is the first case report of PTFJ instability treated surgically with long-term follow-up. Future studies should focus on the long-term satisfactory outcomes of soft tissue stabilization of a chronically unstable PTFJ.

The instability of the proximal tibiofibular joint (PTFJ) is a rare clinical condition that commonly occurs secondary to an initial pivoting or twisting event of a flexed knee. Although acute PTFJ dislocations respond well to closed reduction and casting, the treatment of chronic PTFJ instability presents a unique challenge.¹ Surgical fixation methods include tibiofibular joint recreation using either a split semitendinosus or biceps femoris graft, as well as a Tightrope device.^2-6 Older surgical options for chronic PTFJ instability include fibular head resection or PTFJ arthrodesis.⁷ However, these older techniques have fallen out of favor, and the optimal surgical technique for the treatment of this injury remains a point of contention.

We present the case of an active 26-year-old woman with a 4-year history of recurrent PTFJ subluxations. The patient was surgically treated at our institution by using a split biceps femoris tendon graft for PTFJ reconstruction. This article specifically details the surgical technique used, provides data obtained at the 5-year clinical follow-up, and reviews prior publications on this injury. The patient provided written informed consent for print and electronic publication of this case report.

CASE

A 26-year-old woman presented with a 4-year history of lateral right knee pain with any physical activity. She stated that her pain began immediately following a fall, which was initially treated with casting and immobilization for approximately 6 weeks. After treatment, she began to develop symptoms of “popping on the outside of the knee.” In the 8 months prior to her presentation to our practice, these symptoms had intensified in pain severity and frequency. She reported that the popping events occurred most often with deep squatting.

No gross deformity was observed upon physical examination, and both knees were visibly symmetric. Evidence of effusion was absent. The patient felt no pain with the passive motion of her knee, and she presented the full range of motion (ROM) from 0° to 120°. Anterior drawer, McMurray, Lachman, and pivot shift tests were all negative. Upon the application of manual pressure, the fibular head could be dislocated anteriorly (Video 1). This dislocation recreated the patient’s symptoms. The fibular head could not be subluxed or dislocated posteriorly. Flexing the knee to 90° facilitated reproducing manual anterior dislocation. The contralateral knee was examined and demonstrated no appreciable PTFJ instability. The patient exhibited no other signs of generalized ligamentous laxity. Her sensation in the lower leg was intact, and she reported no tingling or numbness in the peroneal nerve distribution. Tinel’s test of the peroneal nerve was negative.

Continue to: X-ray imaging revealed...

When the patient presented to our office, she reported having undergone several failed efforts of nonoperative treatment, including bracing and activity modification. On the basis of the chronicity of the reported symptoms, level of pain, and the desire of the patient to return to full activity, we recommended the surgical reconstruction of the PTFJ by using a split biceps femoris tendon graft.

OPERATIVE TECHNIQUE

The patient was positioned supine on a Jackson table. General anesthesia was utilized. Biplanar fluoroscopic imaging of the fibula was obtained with the fibular head manually dislocated and reduced. A bump was placed beneath the right thigh to create resting knee flexion. The patient was prepped and draped in sterile fashion, and a tourniquet was applied.

A 10-cm curvilinear surgical incision was made centered over the fibular neck and extending proximally within the interval between the iliotibial band and the biceps femoris tendon. Dissection was performed. The peroneal nerve was identified, carefully dissected out, and then isolated with a vessel loop. The biceps femoris tendon insertion on the fibular head was dissected while ensuring that the nerve was isolated, and the anterior half of the tendon was marked approximately 14 cm proximally using a surgical marker. A 15-blade was then used to split the tendon proximally along the marked path while taking care to preserve the tendinous insertion on the fibular head. The split portion of the tendon was freed from all underlying tissue, and the most distal 2 cm was tubularized using a running baseball stitch and No. 2 Ethibond.

The anterior and posterior aspects of the fibular head were then débrided of tissue, and a guidewire was placed anteriorly-to-posterior. After the position of the guidewire was confirmed with fluoroscopy, a 5-0 cannulated reamer was used to drill through the fibular head. Next, the interval between the biceps femoris and iliotibial band was found, and the lateral head of the gastrocnemius was retracted posteriorly within this interval. A portion of the soleus muscle was also elevated off of the posterior capsule and posterior tibia. The iliotibial band insertion at Gerdy’s tubercle was then identified, and a guidewire was placed from anterior-to-posterior within the tibia, with the starting point just posterior to Gerdy’s tubercle. The wire was advanced under direct visualization with an ACL tibial guide and confirmed fluoroscopically. A 5-mm cannulated reamer was then used to drill over the guidewire through the anterior and posterior cortex of the tibia. A suture passer was passed anterior-to-posterior through this tunnel to retrieve the tubularized portion of the biceps femoris graft, which was then shuttled through the tibial tunnel. This same tubularized graft segment was then shuttled anteriorly-to-posteriorly through the fibular tunnel. At this point, approximately 3 cm of the graft protruded from the posterior aspect of the fibular tunnel.

Continue to: The remaining graft was held...

POSTOPERATIVE COURSE

The patient was initially kept in a knee immobilizer following surgery and instructed to use touch-down weight-bearing for 3 weeks. She was switched to a hinged brace at 1 week postoperatively. Physical therapy began with range of motion exercises, and an active flexion was withheld until 6 weeks postoperatively. After 6 weeks, the patient was allowed to progress to an active ROM and increase to weight-bearing as tolerated.  Strengthening was started at 12 weeks.

MRI was performed at 4 months postoperatively because the patient reported pain with running. The MRI demonstrated no evidence of stress reaction or fracture in the area of reconstruction. She was advised to continue with physical therapy and stop running. At 5-month post-reconstruction, the patient reported that her pain had resolved and that she had no complaints of any peroneal nerve neuropraxia. At 6 months she had returned to normal activity without complaints. At this point, she was instructed to follow-up as needed.

The patient was seen in office 5.5 years after the initial surgery for an unrelated orthopedic issue. At this time, follow-up data were obtained for her PTFJ reconstruction. She stated that she was very satisfied with the results of her surgery. She claimed to be pain free and had been performing normal activities without any difficulty. Upon physical examination, she achieved full range of motion.  She had no extension lag or flexion contracture. She achieved functional and clinical Knee Society Scores of 94 and 90 points, respectively.

DISCUSSION

This article details a soft tissue PTFJ reconstruction using a split biceps femoris graft with over 5 years of clinical follow-up. Chronic PTFJ instability is a rare clinical entity, and unless gross instability is evident upon physical examination, its diagnosis may be confused with the diagnosis of more common complaints, such as meniscal tears or iliotibial band syndrome.

Continue to: Ogden first described...

Past instances of PTFJ instability have been managed with closed reduction and protected weight-bearing, as well as with various open reduction techniques.^2-7 Surgical reconstruction is commonly considered in chronic cases or if nonoperative modalities have failed. Although PTFJ arthrodesis or fibular head resection has been used as a prior treatment option, the postoperative complications associated with each of these techniques have since caused them to fall out of favor.

The split biceps femoris graft has been successfully used in the soft tissue reconstruction of PTFJ.^3,5-7 The soft tissue reconstruction of the PTFJ provides advantages over arthrodesis or fibular head resection because it preserves normal anatomy and avoids secondary stresses to the ankle encountered in the latter procedure. Fibular head resection also presents secondary complications, such as the loss of the biceps femoris and posterolateral corner ligament insertion points.⁹ Similar to this study, prior works have reported returns to functionality. However, this study represents the longest clinical postoperative follow-up of PTFJ ligament reconstruction. By using a split biceps graft, the insertion point of the biceps on the fibular head is preserved, thus maintaining normal function while still allowing for an easily tubularized graft for anatomic PTFJ ligament reconstruction.

CONSLUSION

We present data for over 5 years of follow-up for our surgical approach to this rare pathology. To the best of our knowledge, this is the first case report of PTFJ instability that was treated surgically and with a long-term follow-up. The patient did not demonstrate loss of knee motion, pain, or peroneal nerve symptoms. Moreover, she was very satisfied with the procedure at the most recent follow-up and had returned to unrestricted activity. The soft tissue stabilization of a chronically unstable PTFJ is a viable treatment modality that provides good results, and future studies should confirm these satisfactory outcomes in the long-term.

This paper will be judged for the Resident Writer’s Award.

One-quarter of patients with breast cancer are diagnosed at a premenopausal age and these young women may be directed to discuss oophorectomy with their ob.gyn. This may be because of the discovery of a deleterious BRCA gene mutation, which places them at increased risk for ovarian cancer, but oophorectomy may also be a therapeutic option for their breast cancer: 60% of premenopausal breast cancers are hormone receptor–positive. Ovarian ablation has been associated with improved overall survival and disease-free survival among these patients.¹

Estrogen is an important promoter of breast cancer and is predominantly derived from ovarian tissue in premenopausal women. However, in postmenopausal women, the majority of estrogen is produced peripherally through the conversion of androgens to estrogen via the enzyme aromatase. Aromatase inhibitors, such as exemestane, anastrazole, and letrazole, are drugs which block this conversion in peripheral tissues. They are contraindicated in premenopausal women with intact ovarian function, because there is a reflex pituitary stimulation of ovarian estrogen release in response to suppression of peripheral conversion of androgens. For such patients, ovarian function must be ablated either with surgery or with gonadotropin-releasing hormone (GnRH) analogues such as leuprorelin and goserelin if aromatase inhibitors are desired.

BRCA populations

For women with BRCA germline mutations and a history of breast cancer, oophorectomy is associated with a 70% risk of all-cause mortality, including a 60% reduction in breast cancer mortality. This effect is inclusive of patients with “triple-negative,” hormone receptor–negative tumors. The positive effect on breast cancer mortality is predominantly seen among BRCA-1 mutation carriers, and if the oophorectomy is performed within 2 years of diagnosis.⁵

Technique

When performing oophorectomy either for breast cancer or because of a hereditary cancer syndrome such as BRCA mutation, it is important to ensure that the ovarian vessel pedicle is transected at least 2 cm from its insertion in the ovary. This prevents leaving a residual ovarian remnant. In order to do this, it may be necessary to skeletonize the ovarian vessels free from their physiological attachments to the sigmoid colon on the left, and terminal ileum and cecum on the right. It is also important to ensure that the ureter is not invested in this more proximal segment of ovarian vessels. To prevent this, the retroperitoneal space can be opened lateral to and parallel with the ovarian vessels, and the “medial leaf” of the broad ligament swept medially to expose the ureter as it crosses the bifurcation of the external and internal iliac arteries at the pelvic brim. With the ureter in view, a window can then be made in the “medial leaf” above the ureter and below the ovary and ovarian vessels, in doing so creating a skeletonized ovarian vessel segment which can be sealed and cut 2 cm or more from its insertion in the ovary.

The fallopian tubes should be removed with the ovarian specimens, with attention made to removing the fallopian tube at its junction with the uterine cornua. It should be noted that the majority of fallopian tube cancers arise in the fimbriated end of the tube, and cornual tubal malignancies are fairly uncommon.

The decision about whether or not to perform hysterectomy at the time of salpingo-oophorectomy is complex. In patients without hereditary cancer syndromes, such as BRCA or Lynch syndrome, hysterectomy likely offers no benefit to the patient who is undergoing a procedure for the purpose of ovarian ablation. An argument has been made that hysterectomy can eliminate the increased endometrial cancer risk associated with tamoxifen. However, given the previously discussed data, after oophorectomy, aromatase inhibitors are the preferred treatment option, and tamoxifen can be avoided. If a patient has unrelated underlying uterine pathology a hysterectomy might be indicated. Women with BRCA germline mutations, particularly women with BRCA-1 mutations, may be at increased risk for uterine serous carcinoma, and in these patients, hysterectomy at the time of oophorectomy can be discussed and offered, though as yet, it is not a guideline recommendation for all patients.⁶ Patients who ask to “just take everything out while you are there” without a clear indication for hysterectomy should be counseled that hysterectomy is associated with increased risk, recovery, and cost, compared with bilateral salpingo-oophorectomy. Among patients with elevated surgical risk (such as morbid obesity, known adhesive disease, increased venous thromboembolism risk, diabetes, and so on) it may not always be appropriate to extend the complexity of the procedure given the limited benefit.

Consequences of ovarian ablation

It should be noted that ovarian ablation in the TEXT and SOFT trials was not associated with an increase in overall survival for women with premenopausal breast cancer. Alternatively, large, observational studies such as the Nurses’ Health Study have shown that premenopausal oophorectomy without hormone replacement therapy is associated with increased all-cause mortality. This is primarily driven by the increased cardiopulmonary risk (heart attack and stroke), deaths after osteoporotic hip fractures, and the increased risk for lung and colon cancer.^7,8

It is normal for young patients to have heightened concerns regarding their risk of recurrence from their cancer, and less concerned by threats to their health in decades to come. However, it is important to discuss this data with the patient and allow for her to make an informed decision about her immediate versus future risks. If she determines that she is not interested in permanent ovarian ablation with oophorectomy because of either surgical risks, concerns regarding permanent infertility, or increased all-cause mortality, she still has an option for medical ovarian ablation with GnRH analogues in the treatment of her breast cancer.

Hormone replacement therapy postoperatively

Women who undergo oophorectomy for the treatment of breast cancer should not be offered hormone replacement therapy. This is true even for “triple-negative” or hormone receptor–negative breast cancers as there is still some observed benefit of ovarian ablation, and risk from exogenous hormone administration in these women. Alternatively, postoperative hormone replacement therapy remains safe until the age of natural menopause among premenopausal patients with BRCA germline mutations without a preceding breast cancer diagnosis.

Surgical ovarian ablation with bilateral salpingo-oophorectomy is a valuable strategy in the adjuvant therapy of premenopausal breast cancer, particularly among BRCA mutation carriers and women with hormone receptor–positive disease, or among women who find adherence to medical ablation difficult. Patients should be carefully counseled that this may introduce increased long-term cardiovascular risks for them.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Early Breast Cancer Trialists’ Collaborative Group. Lancet. 1996 Nov 2;348:1189-96.

2. Pagani O et al. N Engl J Med. 2014 Jul 10;371(12):107-18.

3. Francis PA et al. N Engl J Med. 2015 Jan 29;372(5):436-46.

4. Ferrandina G et al. Clin Drug Investig. 2017 Nov;37(11):1093-102.

5. Finch AP et al. J Clin Oncol. 2014 May 20;32(15):1547-53.

6. Shu CA et al. JAMA Oncol. 2016 Nov 1;2(11):1434-40.

7. Parker WH et al. Obstet Gynecol. 2013 Apr;121(4):709-16.

8. Rivera CM et al. Menopause. 2009 Jan-Feb;16:15-23.

One-quarter of patients with breast cancer are diagnosed at a premenopausal age and these young women may be directed to discuss oophorectomy with their ob.gyn. This may be because of the discovery of a deleterious BRCA gene mutation, which places them at increased risk for ovarian cancer, but oophorectomy may also be a therapeutic option for their breast cancer: 60% of premenopausal breast cancers are hormone receptor–positive. Ovarian ablation has been associated with improved overall survival and disease-free survival among these patients.¹

Estrogen is an important promoter of breast cancer and is predominantly derived from ovarian tissue in premenopausal women. However, in postmenopausal women, the majority of estrogen is produced peripherally through the conversion of androgens to estrogen via the enzyme aromatase. Aromatase inhibitors, such as exemestane, anastrazole, and letrazole, are drugs which block this conversion in peripheral tissues. They are contraindicated in premenopausal women with intact ovarian function, because there is a reflex pituitary stimulation of ovarian estrogen release in response to suppression of peripheral conversion of androgens. For such patients, ovarian function must be ablated either with surgery or with gonadotropin-releasing hormone (GnRH) analogues such as leuprorelin and goserelin if aromatase inhibitors are desired.

BRCA populations

For women with BRCA germline mutations and a history of breast cancer, oophorectomy is associated with a 70% risk of all-cause mortality, including a 60% reduction in breast cancer mortality. This effect is inclusive of patients with “triple-negative,” hormone receptor–negative tumors. The positive effect on breast cancer mortality is predominantly seen among BRCA-1 mutation carriers, and if the oophorectomy is performed within 2 years of diagnosis.⁵

Technique

When performing oophorectomy either for breast cancer or because of a hereditary cancer syndrome such as BRCA mutation, it is important to ensure that the ovarian vessel pedicle is transected at least 2 cm from its insertion in the ovary. This prevents leaving a residual ovarian remnant. In order to do this, it may be necessary to skeletonize the ovarian vessels free from their physiological attachments to the sigmoid colon on the left, and terminal ileum and cecum on the right. It is also important to ensure that the ureter is not invested in this more proximal segment of ovarian vessels. To prevent this, the retroperitoneal space can be opened lateral to and parallel with the ovarian vessels, and the “medial leaf” of the broad ligament swept medially to expose the ureter as it crosses the bifurcation of the external and internal iliac arteries at the pelvic brim. With the ureter in view, a window can then be made in the “medial leaf” above the ureter and below the ovary and ovarian vessels, in doing so creating a skeletonized ovarian vessel segment which can be sealed and cut 2 cm or more from its insertion in the ovary.

The fallopian tubes should be removed with the ovarian specimens, with attention made to removing the fallopian tube at its junction with the uterine cornua. It should be noted that the majority of fallopian tube cancers arise in the fimbriated end of the tube, and cornual tubal malignancies are fairly uncommon.

The decision about whether or not to perform hysterectomy at the time of salpingo-oophorectomy is complex. In patients without hereditary cancer syndromes, such as BRCA or Lynch syndrome, hysterectomy likely offers no benefit to the patient who is undergoing a procedure for the purpose of ovarian ablation. An argument has been made that hysterectomy can eliminate the increased endometrial cancer risk associated with tamoxifen. However, given the previously discussed data, after oophorectomy, aromatase inhibitors are the preferred treatment option, and tamoxifen can be avoided. If a patient has unrelated underlying uterine pathology a hysterectomy might be indicated. Women with BRCA germline mutations, particularly women with BRCA-1 mutations, may be at increased risk for uterine serous carcinoma, and in these patients, hysterectomy at the time of oophorectomy can be discussed and offered, though as yet, it is not a guideline recommendation for all patients.⁶ Patients who ask to “just take everything out while you are there” without a clear indication for hysterectomy should be counseled that hysterectomy is associated with increased risk, recovery, and cost, compared with bilateral salpingo-oophorectomy. Among patients with elevated surgical risk (such as morbid obesity, known adhesive disease, increased venous thromboembolism risk, diabetes, and so on) it may not always be appropriate to extend the complexity of the procedure given the limited benefit.

Consequences of ovarian ablation

It should be noted that ovarian ablation in the TEXT and SOFT trials was not associated with an increase in overall survival for women with premenopausal breast cancer. Alternatively, large, observational studies such as the Nurses’ Health Study have shown that premenopausal oophorectomy without hormone replacement therapy is associated with increased all-cause mortality. This is primarily driven by the increased cardiopulmonary risk (heart attack and stroke), deaths after osteoporotic hip fractures, and the increased risk for lung and colon cancer.^7,8

It is normal for young patients to have heightened concerns regarding their risk of recurrence from their cancer, and less concerned by threats to their health in decades to come. However, it is important to discuss this data with the patient and allow for her to make an informed decision about her immediate versus future risks. If she determines that she is not interested in permanent ovarian ablation with oophorectomy because of either surgical risks, concerns regarding permanent infertility, or increased all-cause mortality, she still has an option for medical ovarian ablation with GnRH analogues in the treatment of her breast cancer.

Hormone replacement therapy postoperatively

Women who undergo oophorectomy for the treatment of breast cancer should not be offered hormone replacement therapy. This is true even for “triple-negative” or hormone receptor–negative breast cancers as there is still some observed benefit of ovarian ablation, and risk from exogenous hormone administration in these women. Alternatively, postoperative hormone replacement therapy remains safe until the age of natural menopause among premenopausal patients with BRCA germline mutations without a preceding breast cancer diagnosis.

Surgical ovarian ablation with bilateral salpingo-oophorectomy is a valuable strategy in the adjuvant therapy of premenopausal breast cancer, particularly among BRCA mutation carriers and women with hormone receptor–positive disease, or among women who find adherence to medical ablation difficult. Patients should be carefully counseled that this may introduce increased long-term cardiovascular risks for them.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Early Breast Cancer Trialists’ Collaborative Group. Lancet. 1996 Nov 2;348:1189-96.

2. Pagani O et al. N Engl J Med. 2014 Jul 10;371(12):107-18.

3. Francis PA et al. N Engl J Med. 2015 Jan 29;372(5):436-46.

4. Ferrandina G et al. Clin Drug Investig. 2017 Nov;37(11):1093-102.

5. Finch AP et al. J Clin Oncol. 2014 May 20;32(15):1547-53.

6. Shu CA et al. JAMA Oncol. 2016 Nov 1;2(11):1434-40.

7. Parker WH et al. Obstet Gynecol. 2013 Apr;121(4):709-16.

8. Rivera CM et al. Menopause. 2009 Jan-Feb;16:15-23.

One-quarter of patients with breast cancer are diagnosed at a premenopausal age and these young women may be directed to discuss oophorectomy with their ob.gyn. This may be because of the discovery of a deleterious BRCA gene mutation, which places them at increased risk for ovarian cancer, but oophorectomy may also be a therapeutic option for their breast cancer: 60% of premenopausal breast cancers are hormone receptor–positive. Ovarian ablation has been associated with improved overall survival and disease-free survival among these patients.¹

Estrogen is an important promoter of breast cancer and is predominantly derived from ovarian tissue in premenopausal women. However, in postmenopausal women, the majority of estrogen is produced peripherally through the conversion of androgens to estrogen via the enzyme aromatase. Aromatase inhibitors, such as exemestane, anastrazole, and letrazole, are drugs which block this conversion in peripheral tissues. They are contraindicated in premenopausal women with intact ovarian function, because there is a reflex pituitary stimulation of ovarian estrogen release in response to suppression of peripheral conversion of androgens. For such patients, ovarian function must be ablated either with surgery or with gonadotropin-releasing hormone (GnRH) analogues such as leuprorelin and goserelin if aromatase inhibitors are desired.

BRCA populations

For women with BRCA germline mutations and a history of breast cancer, oophorectomy is associated with a 70% risk of all-cause mortality, including a 60% reduction in breast cancer mortality. This effect is inclusive of patients with “triple-negative,” hormone receptor–negative tumors. The positive effect on breast cancer mortality is predominantly seen among BRCA-1 mutation carriers, and if the oophorectomy is performed within 2 years of diagnosis.⁵

Technique

When performing oophorectomy either for breast cancer or because of a hereditary cancer syndrome such as BRCA mutation, it is important to ensure that the ovarian vessel pedicle is transected at least 2 cm from its insertion in the ovary. This prevents leaving a residual ovarian remnant. In order to do this, it may be necessary to skeletonize the ovarian vessels free from their physiological attachments to the sigmoid colon on the left, and terminal ileum and cecum on the right. It is also important to ensure that the ureter is not invested in this more proximal segment of ovarian vessels. To prevent this, the retroperitoneal space can be opened lateral to and parallel with the ovarian vessels, and the “medial leaf” of the broad ligament swept medially to expose the ureter as it crosses the bifurcation of the external and internal iliac arteries at the pelvic brim. With the ureter in view, a window can then be made in the “medial leaf” above the ureter and below the ovary and ovarian vessels, in doing so creating a skeletonized ovarian vessel segment which can be sealed and cut 2 cm or more from its insertion in the ovary.

The fallopian tubes should be removed with the ovarian specimens, with attention made to removing the fallopian tube at its junction with the uterine cornua. It should be noted that the majority of fallopian tube cancers arise in the fimbriated end of the tube, and cornual tubal malignancies are fairly uncommon.

The decision about whether or not to perform hysterectomy at the time of salpingo-oophorectomy is complex. In patients without hereditary cancer syndromes, such as BRCA or Lynch syndrome, hysterectomy likely offers no benefit to the patient who is undergoing a procedure for the purpose of ovarian ablation. An argument has been made that hysterectomy can eliminate the increased endometrial cancer risk associated with tamoxifen. However, given the previously discussed data, after oophorectomy, aromatase inhibitors are the preferred treatment option, and tamoxifen can be avoided. If a patient has unrelated underlying uterine pathology a hysterectomy might be indicated. Women with BRCA germline mutations, particularly women with BRCA-1 mutations, may be at increased risk for uterine serous carcinoma, and in these patients, hysterectomy at the time of oophorectomy can be discussed and offered, though as yet, it is not a guideline recommendation for all patients.⁶ Patients who ask to “just take everything out while you are there” without a clear indication for hysterectomy should be counseled that hysterectomy is associated with increased risk, recovery, and cost, compared with bilateral salpingo-oophorectomy. Among patients with elevated surgical risk (such as morbid obesity, known adhesive disease, increased venous thromboembolism risk, diabetes, and so on) it may not always be appropriate to extend the complexity of the procedure given the limited benefit.

Consequences of ovarian ablation

It should be noted that ovarian ablation in the TEXT and SOFT trials was not associated with an increase in overall survival for women with premenopausal breast cancer. Alternatively, large, observational studies such as the Nurses’ Health Study have shown that premenopausal oophorectomy without hormone replacement therapy is associated with increased all-cause mortality. This is primarily driven by the increased cardiopulmonary risk (heart attack and stroke), deaths after osteoporotic hip fractures, and the increased risk for lung and colon cancer.^7,8

It is normal for young patients to have heightened concerns regarding their risk of recurrence from their cancer, and less concerned by threats to their health in decades to come. However, it is important to discuss this data with the patient and allow for her to make an informed decision about her immediate versus future risks. If she determines that she is not interested in permanent ovarian ablation with oophorectomy because of either surgical risks, concerns regarding permanent infertility, or increased all-cause mortality, she still has an option for medical ovarian ablation with GnRH analogues in the treatment of her breast cancer.

Hormone replacement therapy postoperatively

Women who undergo oophorectomy for the treatment of breast cancer should not be offered hormone replacement therapy. This is true even for “triple-negative” or hormone receptor–negative breast cancers as there is still some observed benefit of ovarian ablation, and risk from exogenous hormone administration in these women. Alternatively, postoperative hormone replacement therapy remains safe until the age of natural menopause among premenopausal patients with BRCA germline mutations without a preceding breast cancer diagnosis.

Surgical ovarian ablation with bilateral salpingo-oophorectomy is a valuable strategy in the adjuvant therapy of premenopausal breast cancer, particularly among BRCA mutation carriers and women with hormone receptor–positive disease, or among women who find adherence to medical ablation difficult. Patients should be carefully counseled that this may introduce increased long-term cardiovascular risks for them.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Early Breast Cancer Trialists’ Collaborative Group. Lancet. 1996 Nov 2;348:1189-96.

2. Pagani O et al. N Engl J Med. 2014 Jul 10;371(12):107-18.

3. Francis PA et al. N Engl J Med. 2015 Jan 29;372(5):436-46.

4. Ferrandina G et al. Clin Drug Investig. 2017 Nov;37(11):1093-102.

5. Finch AP et al. J Clin Oncol. 2014 May 20;32(15):1547-53.

6. Shu CA et al. JAMA Oncol. 2016 Nov 1;2(11):1434-40.

7. Parker WH et al. Obstet Gynecol. 2013 Apr;121(4):709-16.

8. Rivera CM et al. Menopause. 2009 Jan-Feb;16:15-23.

A new system for remotely assessing and transmitting selected vitals and self-reported measures reduces symptom severity among patients with head and neck cancer receiving radiation therapy, in a randomized trial reported at a press briefing held before the annual meeting of the American Society of Clinical Oncology.

“Head and neck cancer patients who receive radiation treatment have a high symptom burden and also are at increased risk for dehydration during treatment,” said lead study author Susan K. Peterson, PhD, a professor in the department of behavioral science at the University of Texas MD Anderson Cancer Center, Houston. “Previously, we have shown that it was feasible to use mobile and sensor technology to identify treatment-related symptoms and early dehydration risk in patients receiving radiation treatment as part of their outpatient care.”

In the new trial, the investigators tested the CYCORE system (Cyberinfrastructure for Comparative Effectiveness Research), which consists of a Bluetooth-enabled weight scale and blood pressure cuff, and a mobile tablet with a symptom-tracking app that sends information directly to the physician each weekday. A network hub/router was set up in patients’ homes to transmit their sensor readouts, and the mobile app transmitted their symptom data to secure firewall-protected computers. “CYCORE also included a software infrastructure that enabled the analysis and viewing of data in near-real time and was compliant with safety and security and confidentiality standards,” Dr. Peterson noted.

Main trial results showed that compared with peers receiving only usual care (weekly visits with the radiation oncologist), patients receiving usual care augmented with the CYCORE system had lower mean scores on a 10-point scale for general symptoms (0.5-point difference) and for symptoms specific to head and neck cancer (0.6-point difference). In addition, daily remote tracking of patient well-being allowed clinicians to more rapidly detect and respond to symptoms.

“This is important because symptoms can affects patients’ ability to tolerate treatment and can also impact their quality of life during treatment,” Dr. Peterson said.

The mean age of the patients was 60 years; the oldest was 86 years old. “This supports the notion that the use of technology-based interventions can be feasible in older patients,” she maintained. In addition, patients in the CYCORE group showed at least 80% adherence to the daily monitoring tasks.

“We believe that good patient adherence plus the fact that this imposed minimal burden on clinicians for the monitoring supports the use of systems like CYCORE during intensive treatment periods in cancer care, and that using sensor and mobile technology to monitor patients during critical periods of outpatient care can provide a timely source of information for clinical decision making and may ultimately improve quality of life and health outcomes,” Dr. Peterson concluded. “Our next steps would be to explore ways to implement this as part of clinical care, including in community cancer centers, where most patients receive their care.”

“This is yet another application of technology-enabled sharing of information generated at home,” said ASCO President Bruce E. Johnson, MD, FASCO, noting that a similar study last year showed better patient-reported experience and overall survival.

Such technology will likely be increasingly used to obtain timely information that ultimately leads to a reduction in complications, he speculated.

“This information in head and neck cancer is particularly important because patients commonly get a lot of side effects when attempting to swallow enough fluids, such that some centers end up putting a feeding tube into the stomach because it’s so difficult to swallow,” added Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, Boston. “So this is a particularly important clinical application in cancer.”

Study details

The trial population consisted of 357 patients undergoing radiation therapy for head and neck cancer. “We believe that this is the first and largest study of its kind in head and neck cancer,” Dr. Peterson said.

The severity of symptoms and their interference with daily activities were assessed at serial time points with the MD Anderson Symptom Inventory.

In the CYCORE group, 87% of patients measured their blood pressure daily, 86% measured their weight daily, and 80% used the symptom-tracking app daily.

At the end of radiation therapy, the CYCORE patients had lower (i.e., better) mean scores for general symptoms (e.g., pain, nausea, fatigue) relative to usual care counterparts (2.9 vs. 3.4), with a difference still evident 6-8 weeks later (1.6 vs. 1.9) (P = .007).

In addition, the CYCORE patients had lower mean scores for symptoms specific to head and neck cancer (e.g., dysphagia, pain, rash) at the end of radiation therapy (4.2 vs. 4.8), with a difference still evident 6-8 weeks later (1.7 vs. 2.1) (P = .009).

The groups fared essentially the same with respect to scores assessing interference of symptoms with activities of daily living.

Dr. Peterson disclosed that she had no relevant conflicts of interest. The study received funding from the National Institutes of Health.

SOURCE: Peterson et al. ASCO 2018, Abstract 6063.

A new system for remotely assessing and transmitting selected vitals and self-reported measures reduces symptom severity among patients with head and neck cancer receiving radiation therapy, in a randomized trial reported at a press briefing held before the annual meeting of the American Society of Clinical Oncology.

“Head and neck cancer patients who receive radiation treatment have a high symptom burden and also are at increased risk for dehydration during treatment,” said lead study author Susan K. Peterson, PhD, a professor in the department of behavioral science at the University of Texas MD Anderson Cancer Center, Houston. “Previously, we have shown that it was feasible to use mobile and sensor technology to identify treatment-related symptoms and early dehydration risk in patients receiving radiation treatment as part of their outpatient care.”

In the new trial, the investigators tested the CYCORE system (Cyberinfrastructure for Comparative Effectiveness Research), which consists of a Bluetooth-enabled weight scale and blood pressure cuff, and a mobile tablet with a symptom-tracking app that sends information directly to the physician each weekday. A network hub/router was set up in patients’ homes to transmit their sensor readouts, and the mobile app transmitted their symptom data to secure firewall-protected computers. “CYCORE also included a software infrastructure that enabled the analysis and viewing of data in near-real time and was compliant with safety and security and confidentiality standards,” Dr. Peterson noted.

Main trial results showed that compared with peers receiving only usual care (weekly visits with the radiation oncologist), patients receiving usual care augmented with the CYCORE system had lower mean scores on a 10-point scale for general symptoms (0.5-point difference) and for symptoms specific to head and neck cancer (0.6-point difference). In addition, daily remote tracking of patient well-being allowed clinicians to more rapidly detect and respond to symptoms.

“This is important because symptoms can affects patients’ ability to tolerate treatment and can also impact their quality of life during treatment,” Dr. Peterson said.

The mean age of the patients was 60 years; the oldest was 86 years old. “This supports the notion that the use of technology-based interventions can be feasible in older patients,” she maintained. In addition, patients in the CYCORE group showed at least 80% adherence to the daily monitoring tasks.

“We believe that good patient adherence plus the fact that this imposed minimal burden on clinicians for the monitoring supports the use of systems like CYCORE during intensive treatment periods in cancer care, and that using sensor and mobile technology to monitor patients during critical periods of outpatient care can provide a timely source of information for clinical decision making and may ultimately improve quality of life and health outcomes,” Dr. Peterson concluded. “Our next steps would be to explore ways to implement this as part of clinical care, including in community cancer centers, where most patients receive their care.”

“This is yet another application of technology-enabled sharing of information generated at home,” said ASCO President Bruce E. Johnson, MD, FASCO, noting that a similar study last year showed better patient-reported experience and overall survival.

Such technology will likely be increasingly used to obtain timely information that ultimately leads to a reduction in complications, he speculated.

“This information in head and neck cancer is particularly important because patients commonly get a lot of side effects when attempting to swallow enough fluids, such that some centers end up putting a feeding tube into the stomach because it’s so difficult to swallow,” added Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, Boston. “So this is a particularly important clinical application in cancer.”

Study details

The trial population consisted of 357 patients undergoing radiation therapy for head and neck cancer. “We believe that this is the first and largest study of its kind in head and neck cancer,” Dr. Peterson said.

The severity of symptoms and their interference with daily activities were assessed at serial time points with the MD Anderson Symptom Inventory.

In the CYCORE group, 87% of patients measured their blood pressure daily, 86% measured their weight daily, and 80% used the symptom-tracking app daily.

At the end of radiation therapy, the CYCORE patients had lower (i.e., better) mean scores for general symptoms (e.g., pain, nausea, fatigue) relative to usual care counterparts (2.9 vs. 3.4), with a difference still evident 6-8 weeks later (1.6 vs. 1.9) (P = .007).

In addition, the CYCORE patients had lower mean scores for symptoms specific to head and neck cancer (e.g., dysphagia, pain, rash) at the end of radiation therapy (4.2 vs. 4.8), with a difference still evident 6-8 weeks later (1.7 vs. 2.1) (P = .009).

The groups fared essentially the same with respect to scores assessing interference of symptoms with activities of daily living.

Dr. Peterson disclosed that she had no relevant conflicts of interest. The study received funding from the National Institutes of Health.

SOURCE: Peterson et al. ASCO 2018, Abstract 6063.

A new system for remotely assessing and transmitting selected vitals and self-reported measures reduces symptom severity among patients with head and neck cancer receiving radiation therapy, in a randomized trial reported at a press briefing held before the annual meeting of the American Society of Clinical Oncology.

“Head and neck cancer patients who receive radiation treatment have a high symptom burden and also are at increased risk for dehydration during treatment,” said lead study author Susan K. Peterson, PhD, a professor in the department of behavioral science at the University of Texas MD Anderson Cancer Center, Houston. “Previously, we have shown that it was feasible to use mobile and sensor technology to identify treatment-related symptoms and early dehydration risk in patients receiving radiation treatment as part of their outpatient care.”

In the new trial, the investigators tested the CYCORE system (Cyberinfrastructure for Comparative Effectiveness Research), which consists of a Bluetooth-enabled weight scale and blood pressure cuff, and a mobile tablet with a symptom-tracking app that sends information directly to the physician each weekday. A network hub/router was set up in patients’ homes to transmit their sensor readouts, and the mobile app transmitted their symptom data to secure firewall-protected computers. “CYCORE also included a software infrastructure that enabled the analysis and viewing of data in near-real time and was compliant with safety and security and confidentiality standards,” Dr. Peterson noted.

Main trial results showed that compared with peers receiving only usual care (weekly visits with the radiation oncologist), patients receiving usual care augmented with the CYCORE system had lower mean scores on a 10-point scale for general symptoms (0.5-point difference) and for symptoms specific to head and neck cancer (0.6-point difference). In addition, daily remote tracking of patient well-being allowed clinicians to more rapidly detect and respond to symptoms.

“This is important because symptoms can affects patients’ ability to tolerate treatment and can also impact their quality of life during treatment,” Dr. Peterson said.

The mean age of the patients was 60 years; the oldest was 86 years old. “This supports the notion that the use of technology-based interventions can be feasible in older patients,” she maintained. In addition, patients in the CYCORE group showed at least 80% adherence to the daily monitoring tasks.

“We believe that good patient adherence plus the fact that this imposed minimal burden on clinicians for the monitoring supports the use of systems like CYCORE during intensive treatment periods in cancer care, and that using sensor and mobile technology to monitor patients during critical periods of outpatient care can provide a timely source of information for clinical decision making and may ultimately improve quality of life and health outcomes,” Dr. Peterson concluded. “Our next steps would be to explore ways to implement this as part of clinical care, including in community cancer centers, where most patients receive their care.”

“This is yet another application of technology-enabled sharing of information generated at home,” said ASCO President Bruce E. Johnson, MD, FASCO, noting that a similar study last year showed better patient-reported experience and overall survival.

Such technology will likely be increasingly used to obtain timely information that ultimately leads to a reduction in complications, he speculated.

“This information in head and neck cancer is particularly important because patients commonly get a lot of side effects when attempting to swallow enough fluids, such that some centers end up putting a feeding tube into the stomach because it’s so difficult to swallow,” added Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, Boston. “So this is a particularly important clinical application in cancer.”

Study details

The trial population consisted of 357 patients undergoing radiation therapy for head and neck cancer. “We believe that this is the first and largest study of its kind in head and neck cancer,” Dr. Peterson said.

The severity of symptoms and their interference with daily activities were assessed at serial time points with the MD Anderson Symptom Inventory.

In the CYCORE group, 87% of patients measured their blood pressure daily, 86% measured their weight daily, and 80% used the symptom-tracking app daily.

At the end of radiation therapy, the CYCORE patients had lower (i.e., better) mean scores for general symptoms (e.g., pain, nausea, fatigue) relative to usual care counterparts (2.9 vs. 3.4), with a difference still evident 6-8 weeks later (1.6 vs. 1.9) (P = .007).

In addition, the CYCORE patients had lower mean scores for symptoms specific to head and neck cancer (e.g., dysphagia, pain, rash) at the end of radiation therapy (4.2 vs. 4.8), with a difference still evident 6-8 weeks later (1.7 vs. 2.1) (P = .009).

The groups fared essentially the same with respect to scores assessing interference of symptoms with activities of daily living.

Dr. Peterson disclosed that she had no relevant conflicts of interest. The study received funding from the National Institutes of Health.

SOURCE: Peterson et al. ASCO 2018, Abstract 6063.

Read the digital edition here.

Read the digital edition here.

Read the digital edition here.

To the Editor:

Angiokeratoma is a benign vascular tumor characterized by several dilated vessels in the superficial dermis accompanied by epidermal hyperplasia and hyperkeratosis.¹ Angiokeratoma of the vulva is a rare clinical finding, usually involving multiple lesions as part of the Fordyce type.² Solitary angiokeratoma occurs predominantly on the lower legs,³ and although other locations have been described, the presence of a solitary angiokeratoma on the vulva is rare.⁴ We report 2 cases of solitary angiokeratoma on the vulva that was misdiagnosed as malignant melanoma. Both patients were referred to our center for evaluation and excision.

A 65-year-old woman (patient 1) and a 67-year-old woman (patient 2) presented with a bluish black, growing, asymptomatic lesion on the right (Figure 1) and left labia majora, respectively. Both patients were referred by outside physicians for excision because of suspected malignant melanoma. Physical examinations revealed bluish black globular nodules that measured 0.5 and 0.3 cm in diameter, respectively. Dermoscopy (patient 1) revealed dark lacunae. Histopathologic examination of the vulvar lesion (patient 2) showed dilated, blood-filled, vascular spaces in the papillary dermis, accompanied by overlying acanthosis, hyperkeratosis, and papillomatosis that was consistent with angiokeratoma (Figure 2).

Angiokeratoma, particularly the solitary type, often is misdiagnosed. Clinical differential diagnoses may include a wide range of pathologic conditions, including condyloma acuminata, basal cell carcinoma, pyogenic granuloma, lymphangioma, nevi, condyloma lata, nodular prurigo, seborrheic keratosis, granuloma inguinale, and deep fungal infection.^2,5 However, due to its quickly growing nature and its dark complexion, malignant melanoma often is initially diagnosed. Because patients affected by angiokeratoma of the vulva usually are aged 20 to 40 years,⁵ and vulvar melanoma is typical for middle-aged women (median age, 68 years),⁶ this misdiagnosis is more likely in older patients. It should be noted that a high index of suspicion for melanoma often is present when examining the vulva, considering that this area is difficult to monitor, and there is an especially poor prognosis of vulvar melanoma due to its late detection.^6,7

In the past, biopsy was considered mandatory for confirming the diagnosis of vulvar angiokeratoma.^5,8,9 However, dermoscopy has emerged as a valuable tool for diagnosis of angiokeratoma¹⁰ and also was helpful as a diagnostic aid in one of our patients (patient 1). Therefore, we believe that dermoscopy should be performed prior to a biopsy of angiokeratomas of the vulva.

To the Editor:

Angiokeratoma is a benign vascular tumor characterized by several dilated vessels in the superficial dermis accompanied by epidermal hyperplasia and hyperkeratosis.¹ Angiokeratoma of the vulva is a rare clinical finding, usually involving multiple lesions as part of the Fordyce type.² Solitary angiokeratoma occurs predominantly on the lower legs,³ and although other locations have been described, the presence of a solitary angiokeratoma on the vulva is rare.⁴ We report 2 cases of solitary angiokeratoma on the vulva that was misdiagnosed as malignant melanoma. Both patients were referred to our center for evaluation and excision.

A 65-year-old woman (patient 1) and a 67-year-old woman (patient 2) presented with a bluish black, growing, asymptomatic lesion on the right (Figure 1) and left labia majora, respectively. Both patients were referred by outside physicians for excision because of suspected malignant melanoma. Physical examinations revealed bluish black globular nodules that measured 0.5 and 0.3 cm in diameter, respectively. Dermoscopy (patient 1) revealed dark lacunae. Histopathologic examination of the vulvar lesion (patient 2) showed dilated, blood-filled, vascular spaces in the papillary dermis, accompanied by overlying acanthosis, hyperkeratosis, and papillomatosis that was consistent with angiokeratoma (Figure 2).

Angiokeratoma, particularly the solitary type, often is misdiagnosed. Clinical differential diagnoses may include a wide range of pathologic conditions, including condyloma acuminata, basal cell carcinoma, pyogenic granuloma, lymphangioma, nevi, condyloma lata, nodular prurigo, seborrheic keratosis, granuloma inguinale, and deep fungal infection.^2,5 However, due to its quickly growing nature and its dark complexion, malignant melanoma often is initially diagnosed. Because patients affected by angiokeratoma of the vulva usually are aged 20 to 40 years,⁵ and vulvar melanoma is typical for middle-aged women (median age, 68 years),⁶ this misdiagnosis is more likely in older patients. It should be noted that a high index of suspicion for melanoma often is present when examining the vulva, considering that this area is difficult to monitor, and there is an especially poor prognosis of vulvar melanoma due to its late detection.^6,7

In the past, biopsy was considered mandatory for confirming the diagnosis of vulvar angiokeratoma.^5,8,9 However, dermoscopy has emerged as a valuable tool for diagnosis of angiokeratoma¹⁰ and also was helpful as a diagnostic aid in one of our patients (patient 1). Therefore, we believe that dermoscopy should be performed prior to a biopsy of angiokeratomas of the vulva.

To the Editor:

Angiokeratoma is a benign vascular tumor characterized by several dilated vessels in the superficial dermis accompanied by epidermal hyperplasia and hyperkeratosis.¹ Angiokeratoma of the vulva is a rare clinical finding, usually involving multiple lesions as part of the Fordyce type.² Solitary angiokeratoma occurs predominantly on the lower legs,³ and although other locations have been described, the presence of a solitary angiokeratoma on the vulva is rare.⁴ We report 2 cases of solitary angiokeratoma on the vulva that was misdiagnosed as malignant melanoma. Both patients were referred to our center for evaluation and excision.

A 65-year-old woman (patient 1) and a 67-year-old woman (patient 2) presented with a bluish black, growing, asymptomatic lesion on the right (Figure 1) and left labia majora, respectively. Both patients were referred by outside physicians for excision because of suspected malignant melanoma. Physical examinations revealed bluish black globular nodules that measured 0.5 and 0.3 cm in diameter, respectively. Dermoscopy (patient 1) revealed dark lacunae. Histopathologic examination of the vulvar lesion (patient 2) showed dilated, blood-filled, vascular spaces in the papillary dermis, accompanied by overlying acanthosis, hyperkeratosis, and papillomatosis that was consistent with angiokeratoma (Figure 2).

Angiokeratoma, particularly the solitary type, often is misdiagnosed. Clinical differential diagnoses may include a wide range of pathologic conditions, including condyloma acuminata, basal cell carcinoma, pyogenic granuloma, lymphangioma, nevi, condyloma lata, nodular prurigo, seborrheic keratosis, granuloma inguinale, and deep fungal infection.^2,5 However, due to its quickly growing nature and its dark complexion, malignant melanoma often is initially diagnosed. Because patients affected by angiokeratoma of the vulva usually are aged 20 to 40 years,⁵ and vulvar melanoma is typical for middle-aged women (median age, 68 years),⁶ this misdiagnosis is more likely in older patients. It should be noted that a high index of suspicion for melanoma often is present when examining the vulva, considering that this area is difficult to monitor, and there is an especially poor prognosis of vulvar melanoma due to its late detection.^6,7

In the past, biopsy was considered mandatory for confirming the diagnosis of vulvar angiokeratoma.^5,8,9 However, dermoscopy has emerged as a valuable tool for diagnosis of angiokeratoma¹⁰ and also was helpful as a diagnostic aid in one of our patients (patient 1). Therefore, we believe that dermoscopy should be performed prior to a biopsy of angiokeratomas of the vulva.

More frequent follow-up with computed tomography of the thorax and abdomen and serum carcinoembyronic antigen (CEA) testing does not significantly improve mortality rates or improve time to detection of recurrence, results of two studies published in JAMA have suggested.*

In COLOFOL, a randomized clinical trial including more than 2,500 patients with stage II or III colorectal cancer, more frequent follow-up with CT of the thorax and abdomen and serum CEA did not significantly improve 5-year overall mortality or colorectal cancer–specific mortality rates.

In the second study, a retrospective cohort analysis of the National Cancer Database (NCDB) including more than 8,500 patients with stage I-III colorectal cancer, investigators found no significant association between the surveillance testing frequency and time to detection of disease recurrence.
 

Taken together, these findings suggest a need to revisit clinical practice guidelines, Hanna K. Sanoff, MD, of the University of North Carolina at Chapel Hill said in a related editorial (for details, see “Views on the News”).

The COLOFOL randomized trial, reported by Henrik T. Sørensen, DMSc, head of the department of clinical epidemiology at Aarhus (Denmark) University Hospital, and his colleagues, included 2,509 patients with stage II or III colorectal cancer.

“The question of appropriate follow-up intervals has been controversial, and varying intensity of follow-up has been used within and among countries,” Dr. Sørensen and his coauthors said.

Patients were randomized either to a high-frequency group, in which CT and CEA testing were conducted at 6, 12, 18, 24, and 36 months after surgery, or to a low-frequency group that received testing only at 12 and 36 months after surgery.

Results of COLOFOL showed that the 5-year colorectal cancer–specific mortality rate was similar: 10.6% for the high-frequency follow-up group versus 11.4% for the low frequency group (risk difference, 0.8%; 95%confidence interval, –1.7% to 3.3%; P = .52).

Likewise, 5-year overall mortality was 13.0% for the high-frequency group and 14.1% for the low-frequency follow-up groups (risk difference, 1.1%; 95% CI, –1.6% to 3.8%; P = .43

High-intensity testing did result in recurrences being detected earlier; nevertheless, this did not translate into a reduced mortality rate, investigators said.

The retrospective NCDB analysis, reported by George J. Chang, MD, of University of Texas MD Anderson Cancer Center, Houston, and his coauthors, included 8,529 patients with stage I-III colorectal cancer treated at 1,175 facilities.

Facilities designated as high intensity for imaging performed a mean of 2.87 imaging tests over 3 years, compared with 1.63 for facilities designated as low intensity. Median time to detection of recurrence was similar between arms, at 15.1 months for patients treated at centers with high-intensity surveillance versus 16.0 months for those treated at low-intensity surveillance centers (hazard ratio, 0.99; 95% CI, 0.90-1.09).

High-intensity CEA testing facilities performed a mean of 4.31 tests within 3 years versus 1.63 for low-intensity facilities. Again, investigators found similar median time to detection of recurrence for high- and low-intensity facilities (15.9 months versus 15.3 months, respectively; hazard ratio, 1.00; 95% CI, 0.90-1.11)

Previously, the Follow-up After Colorectal Surgery (FACS) study, a randomized controlled trial, showed no survival benefit to more frequent testing, Dr. Chang and his colleagues noted.

“Based on these data and the recent FACS trial, current National Comprehensive Cancer Network (NCCN) guideline recommendations could be considered overtesting given the absence of improvement in recurrence detection or survival,” they wrote, noting that the NCCN guidelines have suggested CT testing every 6 months for 3 years.

Disclosures for the COLOFOL trial included one investigator who reported potential conflicts of interest with Janssen-Cilag and Merck Serono. For the NCDB study, one coauthor reported a potential conflict of interest related to Johnson & Johnson. No other disclosures were reported.

SOURCES: Sørensen HT et al. JAMA Oncol. 2018 May 22. doi: 10.1001/jama.2018.5623; Chang GJ et al. JAMA Oncol. 2018 May 22. doi; 10.1001/jama.2018.5816.

Correction, 6/8/18: An earlier version of this article misstated the name of the journal in which this study was published.

More frequent follow-up with computed tomography of the thorax and abdomen and serum carcinoembyronic antigen (CEA) testing does not significantly improve mortality rates or improve time to detection of recurrence, results of two studies published in JAMA have suggested.*

In COLOFOL, a randomized clinical trial including more than 2,500 patients with stage II or III colorectal cancer, more frequent follow-up with CT of the thorax and abdomen and serum CEA did not significantly improve 5-year overall mortality or colorectal cancer–specific mortality rates.

In the second study, a retrospective cohort analysis of the National Cancer Database (NCDB) including more than 8,500 patients with stage I-III colorectal cancer, investigators found no significant association between the surveillance testing frequency and time to detection of disease recurrence.
 

Taken together, these findings suggest a need to revisit clinical practice guidelines, Hanna K. Sanoff, MD, of the University of North Carolina at Chapel Hill said in a related editorial (for details, see “Views on the News”).

The COLOFOL randomized trial, reported by Henrik T. Sørensen, DMSc, head of the department of clinical epidemiology at Aarhus (Denmark) University Hospital, and his colleagues, included 2,509 patients with stage II or III colorectal cancer.

“The question of appropriate follow-up intervals has been controversial, and varying intensity of follow-up has been used within and among countries,” Dr. Sørensen and his coauthors said.

Patients were randomized either to a high-frequency group, in which CT and CEA testing were conducted at 6, 12, 18, 24, and 36 months after surgery, or to a low-frequency group that received testing only at 12 and 36 months after surgery.

Results of COLOFOL showed that the 5-year colorectal cancer–specific mortality rate was similar: 10.6% for the high-frequency follow-up group versus 11.4% for the low frequency group (risk difference, 0.8%; 95%confidence interval, –1.7% to 3.3%; P = .52).

Likewise, 5-year overall mortality was 13.0% for the high-frequency group and 14.1% for the low-frequency follow-up groups (risk difference, 1.1%; 95% CI, –1.6% to 3.8%; P = .43

High-intensity testing did result in recurrences being detected earlier; nevertheless, this did not translate into a reduced mortality rate, investigators said.

The retrospective NCDB analysis, reported by George J. Chang, MD, of University of Texas MD Anderson Cancer Center, Houston, and his coauthors, included 8,529 patients with stage I-III colorectal cancer treated at 1,175 facilities.

Facilities designated as high intensity for imaging performed a mean of 2.87 imaging tests over 3 years, compared with 1.63 for facilities designated as low intensity. Median time to detection of recurrence was similar between arms, at 15.1 months for patients treated at centers with high-intensity surveillance versus 16.0 months for those treated at low-intensity surveillance centers (hazard ratio, 0.99; 95% CI, 0.90-1.09).

High-intensity CEA testing facilities performed a mean of 4.31 tests within 3 years versus 1.63 for low-intensity facilities. Again, investigators found similar median time to detection of recurrence for high- and low-intensity facilities (15.9 months versus 15.3 months, respectively; hazard ratio, 1.00; 95% CI, 0.90-1.11)

Previously, the Follow-up After Colorectal Surgery (FACS) study, a randomized controlled trial, showed no survival benefit to more frequent testing, Dr. Chang and his colleagues noted.

“Based on these data and the recent FACS trial, current National Comprehensive Cancer Network (NCCN) guideline recommendations could be considered overtesting given the absence of improvement in recurrence detection or survival,” they wrote, noting that the NCCN guidelines have suggested CT testing every 6 months for 3 years.

Disclosures for the COLOFOL trial included one investigator who reported potential conflicts of interest with Janssen-Cilag and Merck Serono. For the NCDB study, one coauthor reported a potential conflict of interest related to Johnson & Johnson. No other disclosures were reported.

SOURCES: Sørensen HT et al. JAMA Oncol. 2018 May 22. doi: 10.1001/jama.2018.5623; Chang GJ et al. JAMA Oncol. 2018 May 22. doi; 10.1001/jama.2018.5816.

Correction, 6/8/18: An earlier version of this article misstated the name of the journal in which this study was published.

More frequent follow-up with computed tomography of the thorax and abdomen and serum carcinoembyronic antigen (CEA) testing does not significantly improve mortality rates or improve time to detection of recurrence, results of two studies published in JAMA have suggested.*

In COLOFOL, a randomized clinical trial including more than 2,500 patients with stage II or III colorectal cancer, more frequent follow-up with CT of the thorax and abdomen and serum CEA did not significantly improve 5-year overall mortality or colorectal cancer–specific mortality rates.

In the second study, a retrospective cohort analysis of the National Cancer Database (NCDB) including more than 8,500 patients with stage I-III colorectal cancer, investigators found no significant association between the surveillance testing frequency and time to detection of disease recurrence.
 

Taken together, these findings suggest a need to revisit clinical practice guidelines, Hanna K. Sanoff, MD, of the University of North Carolina at Chapel Hill said in a related editorial (for details, see “Views on the News”).

The COLOFOL randomized trial, reported by Henrik T. Sørensen, DMSc, head of the department of clinical epidemiology at Aarhus (Denmark) University Hospital, and his colleagues, included 2,509 patients with stage II or III colorectal cancer.

“The question of appropriate follow-up intervals has been controversial, and varying intensity of follow-up has been used within and among countries,” Dr. Sørensen and his coauthors said.

Patients were randomized either to a high-frequency group, in which CT and CEA testing were conducted at 6, 12, 18, 24, and 36 months after surgery, or to a low-frequency group that received testing only at 12 and 36 months after surgery.

Results of COLOFOL showed that the 5-year colorectal cancer–specific mortality rate was similar: 10.6% for the high-frequency follow-up group versus 11.4% for the low frequency group (risk difference, 0.8%; 95%confidence interval, –1.7% to 3.3%; P = .52).

Likewise, 5-year overall mortality was 13.0% for the high-frequency group and 14.1% for the low-frequency follow-up groups (risk difference, 1.1%; 95% CI, –1.6% to 3.8%; P = .43

High-intensity testing did result in recurrences being detected earlier; nevertheless, this did not translate into a reduced mortality rate, investigators said.

The retrospective NCDB analysis, reported by George J. Chang, MD, of University of Texas MD Anderson Cancer Center, Houston, and his coauthors, included 8,529 patients with stage I-III colorectal cancer treated at 1,175 facilities.

Facilities designated as high intensity for imaging performed a mean of 2.87 imaging tests over 3 years, compared with 1.63 for facilities designated as low intensity. Median time to detection of recurrence was similar between arms, at 15.1 months for patients treated at centers with high-intensity surveillance versus 16.0 months for those treated at low-intensity surveillance centers (hazard ratio, 0.99; 95% CI, 0.90-1.09).

High-intensity CEA testing facilities performed a mean of 4.31 tests within 3 years versus 1.63 for low-intensity facilities. Again, investigators found similar median time to detection of recurrence for high- and low-intensity facilities (15.9 months versus 15.3 months, respectively; hazard ratio, 1.00; 95% CI, 0.90-1.11)

Previously, the Follow-up After Colorectal Surgery (FACS) study, a randomized controlled trial, showed no survival benefit to more frequent testing, Dr. Chang and his colleagues noted.

“Based on these data and the recent FACS trial, current National Comprehensive Cancer Network (NCCN) guideline recommendations could be considered overtesting given the absence of improvement in recurrence detection or survival,” they wrote, noting that the NCCN guidelines have suggested CT testing every 6 months for 3 years.

Disclosures for the COLOFOL trial included one investigator who reported potential conflicts of interest with Janssen-Cilag and Merck Serono. For the NCDB study, one coauthor reported a potential conflict of interest related to Johnson & Johnson. No other disclosures were reported.

SOURCES: Sørensen HT et al. JAMA Oncol. 2018 May 22. doi: 10.1001/jama.2018.5623; Chang GJ et al. JAMA Oncol. 2018 May 22. doi; 10.1001/jama.2018.5816.

Correction, 6/8/18: An earlier version of this article misstated the name of the journal in which this study was published.

Use of the recently updated AJCC Cancer Staging Manual, 8th edition, produced about 10% better accuracy when interpreting T1a invasive melanomas in a national study.

For stage T1b or greater cases, using the AJCC 8 instead of the AJCC 7 yielded about 6% higher concordance between interpretations and consensus reference diagnoses, said Joann G. Elmore, MD, MPH, of the David Geffen School of Medicine at the University of California, Los Angeles, and her associates. “Intraobserver reproducibility of diagnoses also improved,” but “concordance and reproducibility remain low,” the researchers wrote. The report was published in JAMA Open Network.

For the study, 187 pathologists each interpreted one of five glass slide sets of melanocytic skin biopsies. At least 8 months later, they interpreted the same set again, both times recording their interpretations on the online Pathology Assessment Tool and Hierarchy for Diagnosis (MPATH-Dx). Researchers then used AJCC 7 and AJCC 8 criteria to group these interpretations into one of five MPATH-Dx classes. The final analysis included only the 116 cases of invasive melanoma, because changes in the AJCC 8 criteria affected only MPATH-Dx classes IV (T1a) and V (T1b and higher), the investigators explained.

For T1a invasive melanomas, overall concordance between interpretations and consensus diagnoses rose from 44% (95% confidence interval, 41%-48%) under the AJCC 7 criteria to 54% (95% CI, 51%-57%) under the AJCC 8 criteria. For stage T1b or higher lesions, concordance rose from 72% to 78%. Intrapathologist reproducibility improved from 59% to 64% for T1a cases and from 74% to 77% for T1b or higher cases. Thus, the AJCC 8 produced “modest” improvements in concordance and reproducibility over the AJCC 7, the researchers said.

One of the most likely explanations is that the AJCC 8 eliminated dermal mitotic activity as a criterion for T1b melanomas, which is “potentially unreliable” in thin lesions, they added. Persistently low concordance and reproducibility “suggest that conventional histopathology has been parsed to a degree that falls below the limits of reliability,” they concluded.

The National Cancer Institute provided funding. Dr. Elmore disclosed ties to Myriad Genetics, SciBase, and the National Institutes of Health.

SOURCE: Elmore JG et al. JAMA Network Open. 2018 May 18. doi: 10.1001/jamanetworkopen.2018.0083.

Use of the recently updated AJCC Cancer Staging Manual, 8th edition, produced about 10% better accuracy when interpreting T1a invasive melanomas in a national study.

For stage T1b or greater cases, using the AJCC 8 instead of the AJCC 7 yielded about 6% higher concordance between interpretations and consensus reference diagnoses, said Joann G. Elmore, MD, MPH, of the David Geffen School of Medicine at the University of California, Los Angeles, and her associates. “Intraobserver reproducibility of diagnoses also improved,” but “concordance and reproducibility remain low,” the researchers wrote. The report was published in JAMA Open Network.

For the study, 187 pathologists each interpreted one of five glass slide sets of melanocytic skin biopsies. At least 8 months later, they interpreted the same set again, both times recording their interpretations on the online Pathology Assessment Tool and Hierarchy for Diagnosis (MPATH-Dx). Researchers then used AJCC 7 and AJCC 8 criteria to group these interpretations into one of five MPATH-Dx classes. The final analysis included only the 116 cases of invasive melanoma, because changes in the AJCC 8 criteria affected only MPATH-Dx classes IV (T1a) and V (T1b and higher), the investigators explained.

For T1a invasive melanomas, overall concordance between interpretations and consensus diagnoses rose from 44% (95% confidence interval, 41%-48%) under the AJCC 7 criteria to 54% (95% CI, 51%-57%) under the AJCC 8 criteria. For stage T1b or higher lesions, concordance rose from 72% to 78%. Intrapathologist reproducibility improved from 59% to 64% for T1a cases and from 74% to 77% for T1b or higher cases. Thus, the AJCC 8 produced “modest” improvements in concordance and reproducibility over the AJCC 7, the researchers said.

One of the most likely explanations is that the AJCC 8 eliminated dermal mitotic activity as a criterion for T1b melanomas, which is “potentially unreliable” in thin lesions, they added. Persistently low concordance and reproducibility “suggest that conventional histopathology has been parsed to a degree that falls below the limits of reliability,” they concluded.

The National Cancer Institute provided funding. Dr. Elmore disclosed ties to Myriad Genetics, SciBase, and the National Institutes of Health.

SOURCE: Elmore JG et al. JAMA Network Open. 2018 May 18. doi: 10.1001/jamanetworkopen.2018.0083.

Use of the recently updated AJCC Cancer Staging Manual, 8th edition, produced about 10% better accuracy when interpreting T1a invasive melanomas in a national study.

For stage T1b or greater cases, using the AJCC 8 instead of the AJCC 7 yielded about 6% higher concordance between interpretations and consensus reference diagnoses, said Joann G. Elmore, MD, MPH, of the David Geffen School of Medicine at the University of California, Los Angeles, and her associates. “Intraobserver reproducibility of diagnoses also improved,” but “concordance and reproducibility remain low,” the researchers wrote. The report was published in JAMA Open Network.

For the study, 187 pathologists each interpreted one of five glass slide sets of melanocytic skin biopsies. At least 8 months later, they interpreted the same set again, both times recording their interpretations on the online Pathology Assessment Tool and Hierarchy for Diagnosis (MPATH-Dx). Researchers then used AJCC 7 and AJCC 8 criteria to group these interpretations into one of five MPATH-Dx classes. The final analysis included only the 116 cases of invasive melanoma, because changes in the AJCC 8 criteria affected only MPATH-Dx classes IV (T1a) and V (T1b and higher), the investigators explained.

For T1a invasive melanomas, overall concordance between interpretations and consensus diagnoses rose from 44% (95% confidence interval, 41%-48%) under the AJCC 7 criteria to 54% (95% CI, 51%-57%) under the AJCC 8 criteria. For stage T1b or higher lesions, concordance rose from 72% to 78%. Intrapathologist reproducibility improved from 59% to 64% for T1a cases and from 74% to 77% for T1b or higher cases. Thus, the AJCC 8 produced “modest” improvements in concordance and reproducibility over the AJCC 7, the researchers said.

One of the most likely explanations is that the AJCC 8 eliminated dermal mitotic activity as a criterion for T1b melanomas, which is “potentially unreliable” in thin lesions, they added. Persistently low concordance and reproducibility “suggest that conventional histopathology has been parsed to a degree that falls below the limits of reliability,” they concluded.

The National Cancer Institute provided funding. Dr. Elmore disclosed ties to Myriad Genetics, SciBase, and the National Institutes of Health.

SOURCE: Elmore JG et al. JAMA Network Open. 2018 May 18. doi: 10.1001/jamanetworkopen.2018.0083.

Patients with inflammatory bowel disease were about 22% more likely to develop Parkinson’s disease than were unaffected peers in a population-based cohort study spanning more than 3 decades.

The finding “strengthens the theory of a ‘gut-brain axis,’ in which the intestinal environment influences the functioning of the central nervous system and intestinal imbalance may precede Parkinson’s disease,” wrote Marie Villumsen, PhD, of Bispebjerg and Frederiksberg Hospital in Copenhagen, with her associates.

Thus, clinicians should be vigilant for parkinsonism in patients with inflammatory bowel disease (IBD), the researchers wrote on May 21 in Gut. “Although the absolute risk of Parkinson’s disease [among patients with IBD] remains low, our study points to overlapping pathogenic mechanisms which merit further investigation, as they may represent targets for future therapeutic interventions.”

Gastrointestinal dysfunction can be one of the earliest manifestations of Parkinson’s disease, the researchers noted. Both neurodegenerative disorders and IBD involve chronic inflammation, and both Crohn’s disease and Parkinson’s disease have been linked to aberrations of the LRRK2 gene, which helps regulate inflammation and clearance of alpha-sinuclein, a key component of neuronal Lewy bodies in Parkinson’s disease.

To assess whether IBD directly increases the risk of Parkinson’s disease, the investigators studied individuals from the Danish National Patient Register, which covers all hospitalizations and outpatient visits in Denmark. They matched 76,477 patients with IBD with 7.5 million unaffected individuals of the same sex and age during 1977-2014. Patients with IBD had significantly more comorbidities (P less than .001) than individuals without IBD, so the researchers also controlled for Charlson Comorbidity Index.

In the adjusted analyses, IBD significantly increased the risk of developing Parkinson’s disease among both men (hazard ratio, 1.2) and women (HR, 1.23), irrespective of follow-up time and regardless of whether patients were less than 40 years old (HR, 1.22), 40-65 years old (HR, 1.25), or older than 65 years (HR, 1.30). The association between IBD and Parkinson’s disease also held up after accounting for the possibility that early gut symptoms of Parkinson’s disease were sometimes misdiagnosed as IBD, the researchers wrote.

Interestingly, stratifying by IBD subtype showed that the statistically significant risk factor was ulcerative colitis (HR, 1.35; 95% confidence interval, 1.20-1.52), not Crohn’s disease (HR, 1.12; 95% CI, 0.89-1.40). Prior studies have found that cigarette smoking reduces the risk of both Parkinson’s disease and ulcerative colitis, the investigators noted. They called for additional studies of intestinal inflammation in Parkinson’s disease and the role of the brain-gut axis in the etiology of parkinsonism.

Parkinsonforeningen, Landsforeningen Multipel System Atrofi, and Aage og Johanne Louis-Hansens Fond provided support. The investigators declared no competing interests.

SOURCE: Villumsen M et al. Gut. 2018 May 21. doi: 10.1136/gutjnl-2017-315666.

Patients with inflammatory bowel disease were about 22% more likely to develop Parkinson’s disease than were unaffected peers in a population-based cohort study spanning more than 3 decades.

The finding “strengthens the theory of a ‘gut-brain axis,’ in which the intestinal environment influences the functioning of the central nervous system and intestinal imbalance may precede Parkinson’s disease,” wrote Marie Villumsen, PhD, of Bispebjerg and Frederiksberg Hospital in Copenhagen, with her associates.

Thus, clinicians should be vigilant for parkinsonism in patients with inflammatory bowel disease (IBD), the researchers wrote on May 21 in Gut. “Although the absolute risk of Parkinson’s disease [among patients with IBD] remains low, our study points to overlapping pathogenic mechanisms which merit further investigation, as they may represent targets for future therapeutic interventions.”

Gastrointestinal dysfunction can be one of the earliest manifestations of Parkinson’s disease, the researchers noted. Both neurodegenerative disorders and IBD involve chronic inflammation, and both Crohn’s disease and Parkinson’s disease have been linked to aberrations of the LRRK2 gene, which helps regulate inflammation and clearance of alpha-sinuclein, a key component of neuronal Lewy bodies in Parkinson’s disease.

To assess whether IBD directly increases the risk of Parkinson’s disease, the investigators studied individuals from the Danish National Patient Register, which covers all hospitalizations and outpatient visits in Denmark. They matched 76,477 patients with IBD with 7.5 million unaffected individuals of the same sex and age during 1977-2014. Patients with IBD had significantly more comorbidities (P less than .001) than individuals without IBD, so the researchers also controlled for Charlson Comorbidity Index.

In the adjusted analyses, IBD significantly increased the risk of developing Parkinson’s disease among both men (hazard ratio, 1.2) and women (HR, 1.23), irrespective of follow-up time and regardless of whether patients were less than 40 years old (HR, 1.22), 40-65 years old (HR, 1.25), or older than 65 years (HR, 1.30). The association between IBD and Parkinson’s disease also held up after accounting for the possibility that early gut symptoms of Parkinson’s disease were sometimes misdiagnosed as IBD, the researchers wrote.

Interestingly, stratifying by IBD subtype showed that the statistically significant risk factor was ulcerative colitis (HR, 1.35; 95% confidence interval, 1.20-1.52), not Crohn’s disease (HR, 1.12; 95% CI, 0.89-1.40). Prior studies have found that cigarette smoking reduces the risk of both Parkinson’s disease and ulcerative colitis, the investigators noted. They called for additional studies of intestinal inflammation in Parkinson’s disease and the role of the brain-gut axis in the etiology of parkinsonism.

Parkinsonforeningen, Landsforeningen Multipel System Atrofi, and Aage og Johanne Louis-Hansens Fond provided support. The investigators declared no competing interests.

SOURCE: Villumsen M et al. Gut. 2018 May 21. doi: 10.1136/gutjnl-2017-315666.

Patients with inflammatory bowel disease were about 22% more likely to develop Parkinson’s disease than were unaffected peers in a population-based cohort study spanning more than 3 decades.

The finding “strengthens the theory of a ‘gut-brain axis,’ in which the intestinal environment influences the functioning of the central nervous system and intestinal imbalance may precede Parkinson’s disease,” wrote Marie Villumsen, PhD, of Bispebjerg and Frederiksberg Hospital in Copenhagen, with her associates.

Thus, clinicians should be vigilant for parkinsonism in patients with inflammatory bowel disease (IBD), the researchers wrote on May 21 in Gut. “Although the absolute risk of Parkinson’s disease [among patients with IBD] remains low, our study points to overlapping pathogenic mechanisms which merit further investigation, as they may represent targets for future therapeutic interventions.”

Gastrointestinal dysfunction can be one of the earliest manifestations of Parkinson’s disease, the researchers noted. Both neurodegenerative disorders and IBD involve chronic inflammation, and both Crohn’s disease and Parkinson’s disease have been linked to aberrations of the LRRK2 gene, which helps regulate inflammation and clearance of alpha-sinuclein, a key component of neuronal Lewy bodies in Parkinson’s disease.

To assess whether IBD directly increases the risk of Parkinson’s disease, the investigators studied individuals from the Danish National Patient Register, which covers all hospitalizations and outpatient visits in Denmark. They matched 76,477 patients with IBD with 7.5 million unaffected individuals of the same sex and age during 1977-2014. Patients with IBD had significantly more comorbidities (P less than .001) than individuals without IBD, so the researchers also controlled for Charlson Comorbidity Index.

In the adjusted analyses, IBD significantly increased the risk of developing Parkinson’s disease among both men (hazard ratio, 1.2) and women (HR, 1.23), irrespective of follow-up time and regardless of whether patients were less than 40 years old (HR, 1.22), 40-65 years old (HR, 1.25), or older than 65 years (HR, 1.30). The association between IBD and Parkinson’s disease also held up after accounting for the possibility that early gut symptoms of Parkinson’s disease were sometimes misdiagnosed as IBD, the researchers wrote.

Interestingly, stratifying by IBD subtype showed that the statistically significant risk factor was ulcerative colitis (HR, 1.35; 95% confidence interval, 1.20-1.52), not Crohn’s disease (HR, 1.12; 95% CI, 0.89-1.40). Prior studies have found that cigarette smoking reduces the risk of both Parkinson’s disease and ulcerative colitis, the investigators noted. They called for additional studies of intestinal inflammation in Parkinson’s disease and the role of the brain-gut axis in the etiology of parkinsonism.

Parkinsonforeningen, Landsforeningen Multipel System Atrofi, and Aage og Johanne Louis-Hansens Fond provided support. The investigators declared no competing interests.

SOURCE: Villumsen M et al. Gut. 2018 May 21. doi: 10.1136/gutjnl-2017-315666.

CAMBRIDGE, MASS. – In the era of biologics, physical therapy still has a place in the treatment of patients with ankylosing spondylitis, according to Angelo Papachristos, an advanced physiotherapist at St. Michaels Hospital in Toronto.

Speaking in an education session at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN), Mr. Papachristos said that therapy should be introduced at diagnosis, individualized, and constantly reevaluated.

“There is no one recommendation,” he said. “Therapy should be monitored and adjusted over time depending on how the patient responds.”

Mr. Papachristos drew attention to two portions of recommendations from the American College of Sports Medicine (ACSM).

First, that scientific evidence demonstrates that the beneficial effects of exercise are indisputable and that the benefits far outweigh the risks.

Second, that a program of regular exercise that includes cardiorespiratory, resistance, flexibility, and neuromotor aspects to improve and maintain fitness and health is essential for most adults.

How much exercise to prescribe and when to introduce exercise remains a question.

[email protected]

CAMBRIDGE, MASS. – In the era of biologics, physical therapy still has a place in the treatment of patients with ankylosing spondylitis, according to Angelo Papachristos, an advanced physiotherapist at St. Michaels Hospital in Toronto.

Speaking in an education session at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN), Mr. Papachristos said that therapy should be introduced at diagnosis, individualized, and constantly reevaluated.

“There is no one recommendation,” he said. “Therapy should be monitored and adjusted over time depending on how the patient responds.”

Mr. Papachristos drew attention to two portions of recommendations from the American College of Sports Medicine (ACSM).

First, that scientific evidence demonstrates that the beneficial effects of exercise are indisputable and that the benefits far outweigh the risks.

Second, that a program of regular exercise that includes cardiorespiratory, resistance, flexibility, and neuromotor aspects to improve and maintain fitness and health is essential for most adults.

How much exercise to prescribe and when to introduce exercise remains a question.

[email protected]

CAMBRIDGE, MASS. – In the era of biologics, physical therapy still has a place in the treatment of patients with ankylosing spondylitis, according to Angelo Papachristos, an advanced physiotherapist at St. Michaels Hospital in Toronto.

Speaking in an education session at the annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN), Mr. Papachristos said that therapy should be introduced at diagnosis, individualized, and constantly reevaluated.

“There is no one recommendation,” he said. “Therapy should be monitored and adjusted over time depending on how the patient responds.”

Mr. Papachristos drew attention to two portions of recommendations from the American College of Sports Medicine (ACSM).

First, that scientific evidence demonstrates that the beneficial effects of exercise are indisputable and that the benefits far outweigh the risks.

Second, that a program of regular exercise that includes cardiorespiratory, resistance, flexibility, and neuromotor aspects to improve and maintain fitness and health is essential for most adults.

How much exercise to prescribe and when to introduce exercise remains a question.

[email protected]

SAN DIEGO – Among patients with idiopathic pulmonary fibrosis (IPF), an improvement in 4-meter gait speed with pulmonary rehabilitation is an independent predictor of all-cause mortality at 1 year, suggest results from a multicenter study presented at an international conference of the American Thoracic Society.

The authors of the study found that patients who improved their gait speed had a longer survival time. In all, 11% of patients died within 1 year of completing pulmonary rehabilitation.

Doug Brunk/MDedge News

“Mortality is an attractive endpoint in IPF clinical research but requires large sample sizes and long follow-up duration, making clinical trials expensive and challenging to undertake,” lead study author Claire M. Nolan, MSc, said at the conference.

“Consequently, there is much interest in surrogate endpoints of mortality. In the elderly population, a lot of work has been done on performance measures, in particular the 4-meter gait test. It’s a simple test to do from the assessor’s perspective, because you just need a 4-meter corridor and a stopwatch. From the patient’s perspective, they only have to walk at their usual speed, making it feasible in most settings.”

The study by Ms. Nolan, a National Institute for Health Research fellow, and her associates, involved recruiting 90 IPF patients referred to three outpatient pulmonary rehabilitation programs in London. All patients underwent the following assessments before and after 8 weeks of pulmonary rehabilitation: spirometry; Medical Research Council dyspnea score; anthropometry; 4-meter gait speed; incremental shuttle walk test, and King’s Brief Interstitial Lung Disease questionnaire. Ms. Nolan, a respiratory physiotherapist with the Harefield Pulmonary Rehabilitation and Muscle Research Group, Royal Brompton and Harefield NHS Foundation Trust, Harefield, London, and her associates drew from national databases to obtain data on all-cause mortality 1 year following pulmonary rehabilitation.

“We also identified a cutpoint, so if patients improved their walking speed by 0.009 meters per second or above, that was associated with a longer survival time at 1 year (area under the curve of 0.76, for sensitivity of 69.6% and a specificity of 70%; P less than 0.01),” she said.* “Among patients who achieved that cutpoint or exceeded it, only 5% of them died in the 1-year follow-up period, compared with 23% in the group that didn’t achieve that cutpoint. That’s quite a big difference, but this requires external validation in another population.”

To determine the 4-meter gait speed change cut-off that best discriminated between patients who died and survived, the investigators plotted receiver operating characteristic curves. For validation, they conducted a Kaplan-Meier analysis to assess time to death, with significance assessed via the log-rank test. Finally, they used a multivariate Cox proportional hazards model to characterize the relationship between 4-meter gait speed change and all-cause mortality, adjusting for independent predictors of mortality (age, previous respiratory hospitalizations in the past year, forced vital capacity percent predicted) and baseline 4-meter gait speed.

At baseline, 70% of the 90 patients were male, mean age was 74 years, mean forced vital capacity was 72.8% predicted, and mean Medical Research Council dyspnea score was 3. In addition, mean body mass index was 27.2 kg/m², mean 4-meter gait speed was 0.92 meters per second, mean incremental shuttle walk test measurement was 271 meters, and mean King’s Brief Interstitial Lung Disease total score was 56.4. Following 8 weeks of pulmonary rehabilitation, the patients’ 4-meter gait speed improved significantly by a mean of 0.15 meters per second (P less than .001). All other variables also improved significantly, with the exception of forced vital capacity.

In an interview, Ms. Nolan characterized the results as “one piece of the puzzle in answering whether 4-meter gait speed is a useful test for clinicians and researchers. It needs to be taken in the context of 4-meter gait speed in other populations as well as with what we’re finding in patients with IPF. We know that this test is reliable, valid, and responsive to treatment. Now we know that it has predictive capacity as well.”

During her presentation, she cited potential reasons why change in gait speed is associated with survival. “Firstly, gait speed has been described as a clinical indicator of multisystem well-being and the ‘sixth vital sign,’ ”she said. “Walking ability and speed rely on multiple factors and the integration of many systems, cardiovascular and otherwise. We know that pulmonary rehab has multiple benefits and improves these systems, and it’s plausible that change in gait speed may be a surrogate marker for, say, improvement in exercise capacity or health status. But the precise mechanism requires verification.”

Ms. Nolan acknowledged certain limitations of the study, including the fact that contemporaneous measurement of full lung function testing and pulmonary hypertension diagnosis were not available at the time of the study. “Therefore, we were unable to account for [diffusing capacity of the lung for carbon monoxide] and pulmonary hypertension diagnosis,” she said. “Secondly, we were unable to identify the precise cause of death from the national database of harm and care records, but this corroborates previous data which suggest that it’s difficult to reliably discern if a death is IPF- or non-IPF related. Lastly, we know that the benefits of pulmonary rehab experienced by IPF patients tend to wane after 6 months. It would be interesting to compare the short-term improvements in gait speed that we observed to more sustained improvements, to identify whether this impacts prognostability.”

National Institute for Health Research funded the study. Ms. Nolan reported having no financial disclosures.

*Correction, 5/23/18: An earlier version of this article misstated the 4-meter gait speed cutoff point. 

[email protected]

SOURCE: Nolan CM et al. ATS 2018, Abstract A2456.

SAN DIEGO – Among patients with idiopathic pulmonary fibrosis (IPF), an improvement in 4-meter gait speed with pulmonary rehabilitation is an independent predictor of all-cause mortality at 1 year, suggest results from a multicenter study presented at an international conference of the American Thoracic Society.

The authors of the study found that patients who improved their gait speed had a longer survival time. In all, 11% of patients died within 1 year of completing pulmonary rehabilitation.

Doug Brunk/MDedge News

“Mortality is an attractive endpoint in IPF clinical research but requires large sample sizes and long follow-up duration, making clinical trials expensive and challenging to undertake,” lead study author Claire M. Nolan, MSc, said at the conference.

“Consequently, there is much interest in surrogate endpoints of mortality. In the elderly population, a lot of work has been done on performance measures, in particular the 4-meter gait test. It’s a simple test to do from the assessor’s perspective, because you just need a 4-meter corridor and a stopwatch. From the patient’s perspective, they only have to walk at their usual speed, making it feasible in most settings.”

The study by Ms. Nolan, a National Institute for Health Research fellow, and her associates, involved recruiting 90 IPF patients referred to three outpatient pulmonary rehabilitation programs in London. All patients underwent the following assessments before and after 8 weeks of pulmonary rehabilitation: spirometry; Medical Research Council dyspnea score; anthropometry; 4-meter gait speed; incremental shuttle walk test, and King’s Brief Interstitial Lung Disease questionnaire. Ms. Nolan, a respiratory physiotherapist with the Harefield Pulmonary Rehabilitation and Muscle Research Group, Royal Brompton and Harefield NHS Foundation Trust, Harefield, London, and her associates drew from national databases to obtain data on all-cause mortality 1 year following pulmonary rehabilitation.

“We also identified a cutpoint, so if patients improved their walking speed by 0.009 meters per second or above, that was associated with a longer survival time at 1 year (area under the curve of 0.76, for sensitivity of 69.6% and a specificity of 70%; P less than 0.01),” she said.* “Among patients who achieved that cutpoint or exceeded it, only 5% of them died in the 1-year follow-up period, compared with 23% in the group that didn’t achieve that cutpoint. That’s quite a big difference, but this requires external validation in another population.”

To determine the 4-meter gait speed change cut-off that best discriminated between patients who died and survived, the investigators plotted receiver operating characteristic curves. For validation, they conducted a Kaplan-Meier analysis to assess time to death, with significance assessed via the log-rank test. Finally, they used a multivariate Cox proportional hazards model to characterize the relationship between 4-meter gait speed change and all-cause mortality, adjusting for independent predictors of mortality (age, previous respiratory hospitalizations in the past year, forced vital capacity percent predicted) and baseline 4-meter gait speed.

At baseline, 70% of the 90 patients were male, mean age was 74 years, mean forced vital capacity was 72.8% predicted, and mean Medical Research Council dyspnea score was 3. In addition, mean body mass index was 27.2 kg/m², mean 4-meter gait speed was 0.92 meters per second, mean incremental shuttle walk test measurement was 271 meters, and mean King’s Brief Interstitial Lung Disease total score was 56.4. Following 8 weeks of pulmonary rehabilitation, the patients’ 4-meter gait speed improved significantly by a mean of 0.15 meters per second (P less than .001). All other variables also improved significantly, with the exception of forced vital capacity.

In an interview, Ms. Nolan characterized the results as “one piece of the puzzle in answering whether 4-meter gait speed is a useful test for clinicians and researchers. It needs to be taken in the context of 4-meter gait speed in other populations as well as with what we’re finding in patients with IPF. We know that this test is reliable, valid, and responsive to treatment. Now we know that it has predictive capacity as well.”

During her presentation, she cited potential reasons why change in gait speed is associated with survival. “Firstly, gait speed has been described as a clinical indicator of multisystem well-being and the ‘sixth vital sign,’ ”she said. “Walking ability and speed rely on multiple factors and the integration of many systems, cardiovascular and otherwise. We know that pulmonary rehab has multiple benefits and improves these systems, and it’s plausible that change in gait speed may be a surrogate marker for, say, improvement in exercise capacity or health status. But the precise mechanism requires verification.”

Ms. Nolan acknowledged certain limitations of the study, including the fact that contemporaneous measurement of full lung function testing and pulmonary hypertension diagnosis were not available at the time of the study. “Therefore, we were unable to account for [diffusing capacity of the lung for carbon monoxide] and pulmonary hypertension diagnosis,” she said. “Secondly, we were unable to identify the precise cause of death from the national database of harm and care records, but this corroborates previous data which suggest that it’s difficult to reliably discern if a death is IPF- or non-IPF related. Lastly, we know that the benefits of pulmonary rehab experienced by IPF patients tend to wane after 6 months. It would be interesting to compare the short-term improvements in gait speed that we observed to more sustained improvements, to identify whether this impacts prognostability.”

National Institute for Health Research funded the study. Ms. Nolan reported having no financial disclosures.

*Correction, 5/23/18: An earlier version of this article misstated the 4-meter gait speed cutoff point. 

[email protected]

SOURCE: Nolan CM et al. ATS 2018, Abstract A2456.

SAN DIEGO – Among patients with idiopathic pulmonary fibrosis (IPF), an improvement in 4-meter gait speed with pulmonary rehabilitation is an independent predictor of all-cause mortality at 1 year, suggest results from a multicenter study presented at an international conference of the American Thoracic Society.

The authors of the study found that patients who improved their gait speed had a longer survival time. In all, 11% of patients died within 1 year of completing pulmonary rehabilitation.

Doug Brunk/MDedge News

“Mortality is an attractive endpoint in IPF clinical research but requires large sample sizes and long follow-up duration, making clinical trials expensive and challenging to undertake,” lead study author Claire M. Nolan, MSc, said at the conference.

“Consequently, there is much interest in surrogate endpoints of mortality. In the elderly population, a lot of work has been done on performance measures, in particular the 4-meter gait test. It’s a simple test to do from the assessor’s perspective, because you just need a 4-meter corridor and a stopwatch. From the patient’s perspective, they only have to walk at their usual speed, making it feasible in most settings.”

The study by Ms. Nolan, a National Institute for Health Research fellow, and her associates, involved recruiting 90 IPF patients referred to three outpatient pulmonary rehabilitation programs in London. All patients underwent the following assessments before and after 8 weeks of pulmonary rehabilitation: spirometry; Medical Research Council dyspnea score; anthropometry; 4-meter gait speed; incremental shuttle walk test, and King’s Brief Interstitial Lung Disease questionnaire. Ms. Nolan, a respiratory physiotherapist with the Harefield Pulmonary Rehabilitation and Muscle Research Group, Royal Brompton and Harefield NHS Foundation Trust, Harefield, London, and her associates drew from national databases to obtain data on all-cause mortality 1 year following pulmonary rehabilitation.

“We also identified a cutpoint, so if patients improved their walking speed by 0.009 meters per second or above, that was associated with a longer survival time at 1 year (area under the curve of 0.76, for sensitivity of 69.6% and a specificity of 70%; P less than 0.01),” she said.* “Among patients who achieved that cutpoint or exceeded it, only 5% of them died in the 1-year follow-up period, compared with 23% in the group that didn’t achieve that cutpoint. That’s quite a big difference, but this requires external validation in another population.”

To determine the 4-meter gait speed change cut-off that best discriminated between patients who died and survived, the investigators plotted receiver operating characteristic curves. For validation, they conducted a Kaplan-Meier analysis to assess time to death, with significance assessed via the log-rank test. Finally, they used a multivariate Cox proportional hazards model to characterize the relationship between 4-meter gait speed change and all-cause mortality, adjusting for independent predictors of mortality (age, previous respiratory hospitalizations in the past year, forced vital capacity percent predicted) and baseline 4-meter gait speed.

At baseline, 70% of the 90 patients were male, mean age was 74 years, mean forced vital capacity was 72.8% predicted, and mean Medical Research Council dyspnea score was 3. In addition, mean body mass index was 27.2 kg/m², mean 4-meter gait speed was 0.92 meters per second, mean incremental shuttle walk test measurement was 271 meters, and mean King’s Brief Interstitial Lung Disease total score was 56.4. Following 8 weeks of pulmonary rehabilitation, the patients’ 4-meter gait speed improved significantly by a mean of 0.15 meters per second (P less than .001). All other variables also improved significantly, with the exception of forced vital capacity.

In an interview, Ms. Nolan characterized the results as “one piece of the puzzle in answering whether 4-meter gait speed is a useful test for clinicians and researchers. It needs to be taken in the context of 4-meter gait speed in other populations as well as with what we’re finding in patients with IPF. We know that this test is reliable, valid, and responsive to treatment. Now we know that it has predictive capacity as well.”

During her presentation, she cited potential reasons why change in gait speed is associated with survival. “Firstly, gait speed has been described as a clinical indicator of multisystem well-being and the ‘sixth vital sign,’ ”she said. “Walking ability and speed rely on multiple factors and the integration of many systems, cardiovascular and otherwise. We know that pulmonary rehab has multiple benefits and improves these systems, and it’s plausible that change in gait speed may be a surrogate marker for, say, improvement in exercise capacity or health status. But the precise mechanism requires verification.”

Ms. Nolan acknowledged certain limitations of the study, including the fact that contemporaneous measurement of full lung function testing and pulmonary hypertension diagnosis were not available at the time of the study. “Therefore, we were unable to account for [diffusing capacity of the lung for carbon monoxide] and pulmonary hypertension diagnosis,” she said. “Secondly, we were unable to identify the precise cause of death from the national database of harm and care records, but this corroborates previous data which suggest that it’s difficult to reliably discern if a death is IPF- or non-IPF related. Lastly, we know that the benefits of pulmonary rehab experienced by IPF patients tend to wane after 6 months. It would be interesting to compare the short-term improvements in gait speed that we observed to more sustained improvements, to identify whether this impacts prognostability.”

National Institute for Health Research funded the study. Ms. Nolan reported having no financial disclosures.

*Correction, 5/23/18: An earlier version of this article misstated the 4-meter gait speed cutoff point. 

[email protected]

SOURCE: Nolan CM et al. ATS 2018, Abstract A2456.