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Breast cancer margin guidelines reduced re-excisions, cost
SCOTTSDALE, ARIZ. – In breast conservation surgery with whole-breast radiation, costs and the number of re-excisions performed at a single institution dropped after the implementation of 2014 consensus guidelines on excision margins.
The guidelines, created by a multidisciplinary margins panel convened by the Society of Surgical Oncology and the American Society for Radiation Oncology recommend “no ink on tumor” as an adequate margin in cases of invasive carcinoma.
The guidelines sought to reduce costs and re-excision rates and improve cosmetic outcomes. The results of the study carried out at the University of Louisville suggest that the guidelines may be successful in achieving these goals. The reduced need for re-excision is a key point. “That’s very traumatic for the patient. With this consensus, we were able to decrease that, improve patient satisfaction, and decrease the cost,” lead author Nicolás Ajkay, MD, assistant professor of surgery at the University of Louisville School of Medicine, said in an interview.
Dr. Ajkay presented the results of the study at the annual meeting of the Western Surgical Association.
“Surgeons need to be aware of the guidelines, and if the margin is close, they need to be in multidisciplinary discussions with other breast cancer experts to determine which patients would benefit from going back to the operating room,” he said.
The researchers examined the experiences of 237 patients with stage I or stage II invasive carcinoma who had a partial mastectomy. Of these patients, 126 underwent the procedure before the university incorporated the guidelines in March 2014 (PRE), while 111 were seen after that date (POST). The study excluded those who were diagnosed by excisional biopsy and those who were treated with neoadjuvant chemotherapy.
Per-patient operative costs went down on average after the guidelines were implemented ($4,247 vs. $5,465; difference, $1,218; P less than .001). The estimated savings for the entire POST cohort of 111 patients was approximately $135,000.
Patient satisfaction improved as measured by the breast satisfaction domain of the BREAST-Q survey tool (77/100 vs. 61/100; P = .03).
A multivariate analysis showed that the implementation of the consensus statement predicted lower re-excision rates (odds ratio, 0.17; 95% confidence interval, 0.08-0.38; P less than .001) as well as lower operative cost per patient (cost greater than $5,465 OR, 0.14; 95% CI, 0.07-0.30; P less than .001). Guideline implementation did not, however, predict decreased total resection volume, or probability of conversion to mastectomy.
Perhaps because diagnostic methods have improved over time, there were some significant differences between the two populations. The PRE group had a larger median tumor size (1.5 cm vs. 1.1 cm; P less than .001), and a lower proportion of the PRE group was diagnosed as stage I (62% vs. 77%; P = .005). The PRE group also had significantly larger initial resection volume (69.3 cm3 versus 47.1 cm3; P = .02), higher selective margin volume (50.0 cm3 vs. 11.3 cm3; P less than .001), and a larger final resection volume (81.0 cm3 vs. 51.5 cm3; P = .05). Additional selective margin resection was less frequent in the PRE group (76% vs. 41%; P less than .001).
Those differences may confound the findings, since outcomes might have been expected to improve anyway due to improvements in care.
One member of the audience asked whether the guidelines might boost rates of cancer recurrence. It’s too soon to tell, according to Dr. Ajkay, who said that researchers will need at least 4 or 5 years of clinical experience to make that determination. But he is optimistic. “Even though we’re excising less, I would predict we will not see an increase in recurrence, because adjuvant therapy is getting significantly better, and adjuvant therapy reduces the risk of recurrence just as margin re-excisions do,” he said.
The study received no external funding. Dr. Ajkay reported having no financial disclosures.
SCOTTSDALE, ARIZ. – In breast conservation surgery with whole-breast radiation, costs and the number of re-excisions performed at a single institution dropped after the implementation of 2014 consensus guidelines on excision margins.
The guidelines, created by a multidisciplinary margins panel convened by the Society of Surgical Oncology and the American Society for Radiation Oncology recommend “no ink on tumor” as an adequate margin in cases of invasive carcinoma.
The guidelines sought to reduce costs and re-excision rates and improve cosmetic outcomes. The results of the study carried out at the University of Louisville suggest that the guidelines may be successful in achieving these goals. The reduced need for re-excision is a key point. “That’s very traumatic for the patient. With this consensus, we were able to decrease that, improve patient satisfaction, and decrease the cost,” lead author Nicolás Ajkay, MD, assistant professor of surgery at the University of Louisville School of Medicine, said in an interview.
Dr. Ajkay presented the results of the study at the annual meeting of the Western Surgical Association.
“Surgeons need to be aware of the guidelines, and if the margin is close, they need to be in multidisciplinary discussions with other breast cancer experts to determine which patients would benefit from going back to the operating room,” he said.
The researchers examined the experiences of 237 patients with stage I or stage II invasive carcinoma who had a partial mastectomy. Of these patients, 126 underwent the procedure before the university incorporated the guidelines in March 2014 (PRE), while 111 were seen after that date (POST). The study excluded those who were diagnosed by excisional biopsy and those who were treated with neoadjuvant chemotherapy.
Per-patient operative costs went down on average after the guidelines were implemented ($4,247 vs. $5,465; difference, $1,218; P less than .001). The estimated savings for the entire POST cohort of 111 patients was approximately $135,000.
Patient satisfaction improved as measured by the breast satisfaction domain of the BREAST-Q survey tool (77/100 vs. 61/100; P = .03).
A multivariate analysis showed that the implementation of the consensus statement predicted lower re-excision rates (odds ratio, 0.17; 95% confidence interval, 0.08-0.38; P less than .001) as well as lower operative cost per patient (cost greater than $5,465 OR, 0.14; 95% CI, 0.07-0.30; P less than .001). Guideline implementation did not, however, predict decreased total resection volume, or probability of conversion to mastectomy.
Perhaps because diagnostic methods have improved over time, there were some significant differences between the two populations. The PRE group had a larger median tumor size (1.5 cm vs. 1.1 cm; P less than .001), and a lower proportion of the PRE group was diagnosed as stage I (62% vs. 77%; P = .005). The PRE group also had significantly larger initial resection volume (69.3 cm3 versus 47.1 cm3; P = .02), higher selective margin volume (50.0 cm3 vs. 11.3 cm3; P less than .001), and a larger final resection volume (81.0 cm3 vs. 51.5 cm3; P = .05). Additional selective margin resection was less frequent in the PRE group (76% vs. 41%; P less than .001).
Those differences may confound the findings, since outcomes might have been expected to improve anyway due to improvements in care.
One member of the audience asked whether the guidelines might boost rates of cancer recurrence. It’s too soon to tell, according to Dr. Ajkay, who said that researchers will need at least 4 or 5 years of clinical experience to make that determination. But he is optimistic. “Even though we’re excising less, I would predict we will not see an increase in recurrence, because adjuvant therapy is getting significantly better, and adjuvant therapy reduces the risk of recurrence just as margin re-excisions do,” he said.
The study received no external funding. Dr. Ajkay reported having no financial disclosures.
SCOTTSDALE, ARIZ. – In breast conservation surgery with whole-breast radiation, costs and the number of re-excisions performed at a single institution dropped after the implementation of 2014 consensus guidelines on excision margins.
The guidelines, created by a multidisciplinary margins panel convened by the Society of Surgical Oncology and the American Society for Radiation Oncology recommend “no ink on tumor” as an adequate margin in cases of invasive carcinoma.
The guidelines sought to reduce costs and re-excision rates and improve cosmetic outcomes. The results of the study carried out at the University of Louisville suggest that the guidelines may be successful in achieving these goals. The reduced need for re-excision is a key point. “That’s very traumatic for the patient. With this consensus, we were able to decrease that, improve patient satisfaction, and decrease the cost,” lead author Nicolás Ajkay, MD, assistant professor of surgery at the University of Louisville School of Medicine, said in an interview.
Dr. Ajkay presented the results of the study at the annual meeting of the Western Surgical Association.
“Surgeons need to be aware of the guidelines, and if the margin is close, they need to be in multidisciplinary discussions with other breast cancer experts to determine which patients would benefit from going back to the operating room,” he said.
The researchers examined the experiences of 237 patients with stage I or stage II invasive carcinoma who had a partial mastectomy. Of these patients, 126 underwent the procedure before the university incorporated the guidelines in March 2014 (PRE), while 111 were seen after that date (POST). The study excluded those who were diagnosed by excisional biopsy and those who were treated with neoadjuvant chemotherapy.
Per-patient operative costs went down on average after the guidelines were implemented ($4,247 vs. $5,465; difference, $1,218; P less than .001). The estimated savings for the entire POST cohort of 111 patients was approximately $135,000.
Patient satisfaction improved as measured by the breast satisfaction domain of the BREAST-Q survey tool (77/100 vs. 61/100; P = .03).
A multivariate analysis showed that the implementation of the consensus statement predicted lower re-excision rates (odds ratio, 0.17; 95% confidence interval, 0.08-0.38; P less than .001) as well as lower operative cost per patient (cost greater than $5,465 OR, 0.14; 95% CI, 0.07-0.30; P less than .001). Guideline implementation did not, however, predict decreased total resection volume, or probability of conversion to mastectomy.
Perhaps because diagnostic methods have improved over time, there were some significant differences between the two populations. The PRE group had a larger median tumor size (1.5 cm vs. 1.1 cm; P less than .001), and a lower proportion of the PRE group was diagnosed as stage I (62% vs. 77%; P = .005). The PRE group also had significantly larger initial resection volume (69.3 cm3 versus 47.1 cm3; P = .02), higher selective margin volume (50.0 cm3 vs. 11.3 cm3; P less than .001), and a larger final resection volume (81.0 cm3 vs. 51.5 cm3; P = .05). Additional selective margin resection was less frequent in the PRE group (76% vs. 41%; P less than .001).
Those differences may confound the findings, since outcomes might have been expected to improve anyway due to improvements in care.
One member of the audience asked whether the guidelines might boost rates of cancer recurrence. It’s too soon to tell, according to Dr. Ajkay, who said that researchers will need at least 4 or 5 years of clinical experience to make that determination. But he is optimistic. “Even though we’re excising less, I would predict we will not see an increase in recurrence, because adjuvant therapy is getting significantly better, and adjuvant therapy reduces the risk of recurrence just as margin re-excisions do,” he said.
The study received no external funding. Dr. Ajkay reported having no financial disclosures.
AT WSA 2017
Key clinical point: Breast cancer margin guidelines may help reduce re-excisions and lower costs.
Major finding: Operative costs per patient fell by $1,218 after the adoption of the “no ink on tumor” guidelines.
Data source: Retrospective analysis of 237 patients undergoing breast conservation surgery.
Disclosures: The study received no external funding. Dr. Ajkay reported having no financial disclosures.
New persistent opioid use common after cancer surgery
New and persistent opioid use is a common complication of surgery in patients with early-stage cancer, according to results of a retrospective cohort study.
The risk of new persistent opioid use was 10.4% (95% confidence interval, 10.1%-10.7%) among patients undergoing curative-intent cancer surgery, according to the report, which was based on examination of 68,463 deidentified insurance claims from employer health plans from 2010 to 2014.
“This problem requires changes to prescribing guidelines and patient counseling during the surveillance and survivorship phases of care,” wrote Jay Soong-Jin Lee, MD, and his colleagues at the University of Michigan, Ann Arbor (J Clin Oncol. 2017 Oct 19. doi: 10.1200/JCO.2017.74.1363).
One year after the surgery, patients who developed new persistent opioid use were still filling prescriptions at high daily opioid doses, equivalent to six hydrocodone 5-mg tablets per day, according Dr. Lee and his colleagues.
“This dose is similar to intermittent and chronic opioid users [in the insurance claim data], suggesting that patients with new persistent opioid use may transition to chronic opioid use,” they said in the study report.
Adjuvant chemotherapy was a “strong risk factor” for new persistent opioid use, they added, though use was still common among patients who had no adjuvant chemotherapy. Rates of new persistent opioid use ranged from 15% to 21% for adjuvant therapy patient groups, compared with 7%-11% for no advjuvant therapy, data show.
Previous studies suggested a 6%-8% risk of new persistent opioid use among surgical patients, but those studies either did not focus on cancer patients or excluded them entirely, Dr. Lee and his coauthors noted.
Strategies are needed to combat new persistent opioid use after curative-intent surgery, they added.
They recommended further study to develop evidence-based guidelines to reduce excessive opioid prescribing and screening tools to identify at-risk patients (e.g., those with psychosocial factors).
Surgeons should be more active in counseling patients on the potential risks of opioids and how to keep use to a minimum after surgery, they added.
“Given the high risk of new persistent opioid use in this population, physicians should consider universal precautions … including educating patients on safe use, storage, and disposal,” they wrote.
Dr. Lee disclosed no relationships relevant to the study, while several coauthors reported relationships with Neuros Medical, Merck, and Anesthesia Associates of Ann Arbor.
New and persistent opioid use is a common complication of surgery in patients with early-stage cancer, according to results of a retrospective cohort study.
The risk of new persistent opioid use was 10.4% (95% confidence interval, 10.1%-10.7%) among patients undergoing curative-intent cancer surgery, according to the report, which was based on examination of 68,463 deidentified insurance claims from employer health plans from 2010 to 2014.
“This problem requires changes to prescribing guidelines and patient counseling during the surveillance and survivorship phases of care,” wrote Jay Soong-Jin Lee, MD, and his colleagues at the University of Michigan, Ann Arbor (J Clin Oncol. 2017 Oct 19. doi: 10.1200/JCO.2017.74.1363).
One year after the surgery, patients who developed new persistent opioid use were still filling prescriptions at high daily opioid doses, equivalent to six hydrocodone 5-mg tablets per day, according Dr. Lee and his colleagues.
“This dose is similar to intermittent and chronic opioid users [in the insurance claim data], suggesting that patients with new persistent opioid use may transition to chronic opioid use,” they said in the study report.
Adjuvant chemotherapy was a “strong risk factor” for new persistent opioid use, they added, though use was still common among patients who had no adjuvant chemotherapy. Rates of new persistent opioid use ranged from 15% to 21% for adjuvant therapy patient groups, compared with 7%-11% for no advjuvant therapy, data show.
Previous studies suggested a 6%-8% risk of new persistent opioid use among surgical patients, but those studies either did not focus on cancer patients or excluded them entirely, Dr. Lee and his coauthors noted.
Strategies are needed to combat new persistent opioid use after curative-intent surgery, they added.
They recommended further study to develop evidence-based guidelines to reduce excessive opioid prescribing and screening tools to identify at-risk patients (e.g., those with psychosocial factors).
Surgeons should be more active in counseling patients on the potential risks of opioids and how to keep use to a minimum after surgery, they added.
“Given the high risk of new persistent opioid use in this population, physicians should consider universal precautions … including educating patients on safe use, storage, and disposal,” they wrote.
Dr. Lee disclosed no relationships relevant to the study, while several coauthors reported relationships with Neuros Medical, Merck, and Anesthesia Associates of Ann Arbor.
New and persistent opioid use is a common complication of surgery in patients with early-stage cancer, according to results of a retrospective cohort study.
The risk of new persistent opioid use was 10.4% (95% confidence interval, 10.1%-10.7%) among patients undergoing curative-intent cancer surgery, according to the report, which was based on examination of 68,463 deidentified insurance claims from employer health plans from 2010 to 2014.
“This problem requires changes to prescribing guidelines and patient counseling during the surveillance and survivorship phases of care,” wrote Jay Soong-Jin Lee, MD, and his colleagues at the University of Michigan, Ann Arbor (J Clin Oncol. 2017 Oct 19. doi: 10.1200/JCO.2017.74.1363).
One year after the surgery, patients who developed new persistent opioid use were still filling prescriptions at high daily opioid doses, equivalent to six hydrocodone 5-mg tablets per day, according Dr. Lee and his colleagues.
“This dose is similar to intermittent and chronic opioid users [in the insurance claim data], suggesting that patients with new persistent opioid use may transition to chronic opioid use,” they said in the study report.
Adjuvant chemotherapy was a “strong risk factor” for new persistent opioid use, they added, though use was still common among patients who had no adjuvant chemotherapy. Rates of new persistent opioid use ranged from 15% to 21% for adjuvant therapy patient groups, compared with 7%-11% for no advjuvant therapy, data show.
Previous studies suggested a 6%-8% risk of new persistent opioid use among surgical patients, but those studies either did not focus on cancer patients or excluded them entirely, Dr. Lee and his coauthors noted.
Strategies are needed to combat new persistent opioid use after curative-intent surgery, they added.
They recommended further study to develop evidence-based guidelines to reduce excessive opioid prescribing and screening tools to identify at-risk patients (e.g., those with psychosocial factors).
Surgeons should be more active in counseling patients on the potential risks of opioids and how to keep use to a minimum after surgery, they added.
“Given the high risk of new persistent opioid use in this population, physicians should consider universal precautions … including educating patients on safe use, storage, and disposal,” they wrote.
Dr. Lee disclosed no relationships relevant to the study, while several coauthors reported relationships with Neuros Medical, Merck, and Anesthesia Associates of Ann Arbor.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Prescribing guidelines and patient counseling need to change to combat new persistent opioid use, which authors confirmed is a common problem in patients undergoing surgery for early-stage cancer.
Major finding: The risk of new persistent opioid use was 10.4% (95% CI, 10.1%-10.7%) among patients undergoing curative-intent cancer surgery.
Data source: Retrospective cohort study based on examination of deidentified insurance claims from employer health plans from 2010 to 2014.
Disclosures: First author Jay Soong-Jin Lee, MD, had no relationships to disclose. Coauthors reported relationships with Neuros Medical and Merck and Anesthesia Associates of Ann Arbor.
Perioperative blood transfusion linked to worse outcomes in renal cell carcinoma
Perioperative blood transfusion (PBT) is associated with poorer outcomes among patients who underwent nephrectomy for renal cell carcinoma (RCC), according to a retrospective review of 1,159 patients.
Using multivariate analysis and controlling for potential confounders such as clinical and pathologic features, receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).
Previous research suggests that PBT may be associated with worse oncological outcomes following cancer surgery, although the data have been inconsistent. In this study, Dr. Abu-Ghanem and colleagues conducted a retrospective study that examined effect of PBT on the prognosis of 1,159 patients who underwent radical nephrectomy or partial nephrectomy for RCC, between 1987 to 2013.
Within this cohort, 198 patients (17.1%) received a PBT, and the median follow-up was 63.2 months. Receipt of PBT was associated with a symptomatic presentation (P less than .001) and a higher rate of adverse pathological features that included larger tumors (P less than .001), high nuclear grade (P less than .001), presence of tumor necrosis (P less than .001), and capsular invasion (P less than .001). Patients who received PBT were also more likely to have undergone an open surgical procedure (P less than .05).
The authors found that receipt of a PBT was associated with significantly worse 5-year relapse free survival (81% vs. 92%, P less than .01) as well as metastatic free survival (79% vs. 93%, P less than .001). Receiving a PBT was also associated with a worse 5-year CSS (85% vs. 95%, P less than .001) and OS (73% vs. 81%, P less than .001) versus those who were not transfused.
A subgroup analysis showed that patients who underwent a partial nephrectomy also had worse outcomes if they received a PBT as compared to those who didn’t; 5-year relapse free survival was 81% vs. 90% (P = .014), CSS was 89% vs. 97% (P = .019) and OS was 82% vs. 92%, (P = .016).
There were no funding sources or author disclosures listed in the article.
Perioperative blood transfusion (PBT) is associated with poorer outcomes among patients who underwent nephrectomy for renal cell carcinoma (RCC), according to a retrospective review of 1,159 patients.
Using multivariate analysis and controlling for potential confounders such as clinical and pathologic features, receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).
Previous research suggests that PBT may be associated with worse oncological outcomes following cancer surgery, although the data have been inconsistent. In this study, Dr. Abu-Ghanem and colleagues conducted a retrospective study that examined effect of PBT on the prognosis of 1,159 patients who underwent radical nephrectomy or partial nephrectomy for RCC, between 1987 to 2013.
Within this cohort, 198 patients (17.1%) received a PBT, and the median follow-up was 63.2 months. Receipt of PBT was associated with a symptomatic presentation (P less than .001) and a higher rate of adverse pathological features that included larger tumors (P less than .001), high nuclear grade (P less than .001), presence of tumor necrosis (P less than .001), and capsular invasion (P less than .001). Patients who received PBT were also more likely to have undergone an open surgical procedure (P less than .05).
The authors found that receipt of a PBT was associated with significantly worse 5-year relapse free survival (81% vs. 92%, P less than .01) as well as metastatic free survival (79% vs. 93%, P less than .001). Receiving a PBT was also associated with a worse 5-year CSS (85% vs. 95%, P less than .001) and OS (73% vs. 81%, P less than .001) versus those who were not transfused.
A subgroup analysis showed that patients who underwent a partial nephrectomy also had worse outcomes if they received a PBT as compared to those who didn’t; 5-year relapse free survival was 81% vs. 90% (P = .014), CSS was 89% vs. 97% (P = .019) and OS was 82% vs. 92%, (P = .016).
There were no funding sources or author disclosures listed in the article.
Perioperative blood transfusion (PBT) is associated with poorer outcomes among patients who underwent nephrectomy for renal cell carcinoma (RCC), according to a retrospective review of 1,159 patients.
Using multivariate analysis and controlling for potential confounders such as clinical and pathologic features, receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).
Previous research suggests that PBT may be associated with worse oncological outcomes following cancer surgery, although the data have been inconsistent. In this study, Dr. Abu-Ghanem and colleagues conducted a retrospective study that examined effect of PBT on the prognosis of 1,159 patients who underwent radical nephrectomy or partial nephrectomy for RCC, between 1987 to 2013.
Within this cohort, 198 patients (17.1%) received a PBT, and the median follow-up was 63.2 months. Receipt of PBT was associated with a symptomatic presentation (P less than .001) and a higher rate of adverse pathological features that included larger tumors (P less than .001), high nuclear grade (P less than .001), presence of tumor necrosis (P less than .001), and capsular invasion (P less than .001). Patients who received PBT were also more likely to have undergone an open surgical procedure (P less than .05).
The authors found that receipt of a PBT was associated with significantly worse 5-year relapse free survival (81% vs. 92%, P less than .01) as well as metastatic free survival (79% vs. 93%, P less than .001). Receiving a PBT was also associated with a worse 5-year CSS (85% vs. 95%, P less than .001) and OS (73% vs. 81%, P less than .001) versus those who were not transfused.
A subgroup analysis showed that patients who underwent a partial nephrectomy also had worse outcomes if they received a PBT as compared to those who didn’t; 5-year relapse free survival was 81% vs. 90% (P = .014), CSS was 89% vs. 97% (P = .019) and OS was 82% vs. 92%, (P = .016).
There were no funding sources or author disclosures listed in the article.
FROM UROLOGIC ONCOLOGY
Key clinical point: Major finding: Receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).
Data source: Retrospective study that included 1,159 patients with RCC who underwent nephrectomy and evaluated outcomes in those who received a PBT versus those who did not.
Disclosures: There are no funding sources or author disclosures listed.
Papillary thyroid microcarcinoma: Is ‘less is more’ the right approach?
Surgeons treated 95% of preoperatively diagnosed cases of papillary thyroid microcarcinoma with total thyroidectomy, compared with only 69% of postoperatively diagnosed cases, in to a single-center retrospective cohort study.
“During the study period, thyroid lobectomy was an acceptable alternative endorsed by the American Thyroid Association,” said Susan C. Pitt, MD, and her associates at the University of Wisconsin, Madison. “Nonetheless, documentation rarely stated that [thyroid lobectomy] was discussed as an option. Whether this finding indicates a true lack of discussion or a deficit in documentation is unclear, but emphasizes the need to improve the quality of the [electronic health record] and capture all elements of shared decision-making.”
Papillary thyroid microcarcinomas (PTMC) measure 1 cm or less, affect up to a third of adults, and explain about half of the recent rise in rates of papillary thyroid cancer, the investigators stated. Most cases are found incidentally and there is no evidence that they contribute to a rise in mortality, which stands at about 0.5 deaths per 100,000 diagnoses of thyroid carcinoma. Accordingly, in 2015, the American Thyroid Association (ATA) endorsed active surveillance and thyroid lobectomy as acceptable management strategies for most patients with PTMC (Thyroid. 2016 Jan 12;26[1]:1-133).
“The pendulum for the ATA guidelines has swung back and forth,” Dr. Pitt said in an interview. “I think the current 2015 ATA guidelines are still controversial – some surgeons and endocrinologists think we have swung too far [in the other direction]. Moving the field from total thyroidectomy to active surveillance is a big jump. Understanding the factors underlying current decisions will help us to implement less extensive management, like lobectomy and active surveillance.”
To do that, Dr. Pitt and her associates reviewed medical records from 125 patients with PTMC treated at the University of Wisconsin between 2008 and 2016. Most of the patients (90%) were white, 85% were female, average age was 50 years, and nearly all had classic or follicular-variant disease. Only 27% of patients underwent thyroid lobectomy; the rest underwent total thyroidectomy. Furthermore, among 19 patients diagnosed preoperatively, 95% underwent total thyroidectomy and 21% had a complication, including one (5%) case of permanent hypocalcemia that less extensive surgery might have avoided (J Surg Res. 2017;218:237-45).
“In all cases, documentation indicated that these preoperatively diagnosed patients followed the surgeon’s recommendation regarding the extent of surgery,” the researchers wrote. Surgeons cited various reasons for recommending total thyroidectomy, including – in about 20% of cases – a belief that it was the recommended treatment.
Only one of the 19 preoperatively diagnosed patients had a documented discussion of thyroid lobectomy, the researchers found.
While physicians might be concerned about recurrence or other “downstream” outcomes of a less-is-more approach to PTMC, Dr. Pitt noted that, in a recent large study, only 3.4% of these tumors metastasized over 10 years (World J Surg. 2010 Jan;34[1]:28-35).
“At the same time, I think that we have a better sense [that] patient-centered outcomes after thyroidectomy, such as health-related quality of life, swallowing, and voice outcomes, can be worse after a total thyroidectomy,” she added.
As surgical and medical therapies expand for PTMC and other nonmalignant diseases, it becomes increasingly vital that surgeons and patients undertake shared decision-making, she said. At the University of Wisconsin, physicians can enter free text in the EHR to document such discussions. She gave an example of how she does that: “‘Total thyroidectomy and lobectomy are both appropriate approaches for Ms. Smith. We discussed these options at length, including X, Y, and Z. Given Mrs. Smith’s (strong) preference to avoid X, we will proceed with a lobectomy.”
In her own practice, Dr. Pitt added, “when I look back at a note, I want to know what the decision was, and why it was made.”
Shared decision-making differs from informed consent by focusing on patient preferences, she noted. “I have used my notes in the operating room to help me decide what to do. I can look back and have a window into our conversation and what an individual patient values.” For PTMC, shared decisions should focus less on cancer risk and more on quality of life and outcomes a year later, she said.
“Patients don’t die from PTMC, and most live longer than the age-matched population. Given the risks of more extensive surgery and our current data on surgical and patient-centered outcomes, I think that thyroid lobectomy should be the initial treatment for most patients with PTMC, and surgeons should help their patients make informed decisions,” Dr. Pitt said.
The National Institutes of Health provided funding. The researchers reported having no conflicts of interest.
Surgeons treated 95% of preoperatively diagnosed cases of papillary thyroid microcarcinoma with total thyroidectomy, compared with only 69% of postoperatively diagnosed cases, in to a single-center retrospective cohort study.
“During the study period, thyroid lobectomy was an acceptable alternative endorsed by the American Thyroid Association,” said Susan C. Pitt, MD, and her associates at the University of Wisconsin, Madison. “Nonetheless, documentation rarely stated that [thyroid lobectomy] was discussed as an option. Whether this finding indicates a true lack of discussion or a deficit in documentation is unclear, but emphasizes the need to improve the quality of the [electronic health record] and capture all elements of shared decision-making.”
Papillary thyroid microcarcinomas (PTMC) measure 1 cm or less, affect up to a third of adults, and explain about half of the recent rise in rates of papillary thyroid cancer, the investigators stated. Most cases are found incidentally and there is no evidence that they contribute to a rise in mortality, which stands at about 0.5 deaths per 100,000 diagnoses of thyroid carcinoma. Accordingly, in 2015, the American Thyroid Association (ATA) endorsed active surveillance and thyroid lobectomy as acceptable management strategies for most patients with PTMC (Thyroid. 2016 Jan 12;26[1]:1-133).
“The pendulum for the ATA guidelines has swung back and forth,” Dr. Pitt said in an interview. “I think the current 2015 ATA guidelines are still controversial – some surgeons and endocrinologists think we have swung too far [in the other direction]. Moving the field from total thyroidectomy to active surveillance is a big jump. Understanding the factors underlying current decisions will help us to implement less extensive management, like lobectomy and active surveillance.”
To do that, Dr. Pitt and her associates reviewed medical records from 125 patients with PTMC treated at the University of Wisconsin between 2008 and 2016. Most of the patients (90%) were white, 85% were female, average age was 50 years, and nearly all had classic or follicular-variant disease. Only 27% of patients underwent thyroid lobectomy; the rest underwent total thyroidectomy. Furthermore, among 19 patients diagnosed preoperatively, 95% underwent total thyroidectomy and 21% had a complication, including one (5%) case of permanent hypocalcemia that less extensive surgery might have avoided (J Surg Res. 2017;218:237-45).
“In all cases, documentation indicated that these preoperatively diagnosed patients followed the surgeon’s recommendation regarding the extent of surgery,” the researchers wrote. Surgeons cited various reasons for recommending total thyroidectomy, including – in about 20% of cases – a belief that it was the recommended treatment.
Only one of the 19 preoperatively diagnosed patients had a documented discussion of thyroid lobectomy, the researchers found.
While physicians might be concerned about recurrence or other “downstream” outcomes of a less-is-more approach to PTMC, Dr. Pitt noted that, in a recent large study, only 3.4% of these tumors metastasized over 10 years (World J Surg. 2010 Jan;34[1]:28-35).
“At the same time, I think that we have a better sense [that] patient-centered outcomes after thyroidectomy, such as health-related quality of life, swallowing, and voice outcomes, can be worse after a total thyroidectomy,” she added.
As surgical and medical therapies expand for PTMC and other nonmalignant diseases, it becomes increasingly vital that surgeons and patients undertake shared decision-making, she said. At the University of Wisconsin, physicians can enter free text in the EHR to document such discussions. She gave an example of how she does that: “‘Total thyroidectomy and lobectomy are both appropriate approaches for Ms. Smith. We discussed these options at length, including X, Y, and Z. Given Mrs. Smith’s (strong) preference to avoid X, we will proceed with a lobectomy.”
In her own practice, Dr. Pitt added, “when I look back at a note, I want to know what the decision was, and why it was made.”
Shared decision-making differs from informed consent by focusing on patient preferences, she noted. “I have used my notes in the operating room to help me decide what to do. I can look back and have a window into our conversation and what an individual patient values.” For PTMC, shared decisions should focus less on cancer risk and more on quality of life and outcomes a year later, she said.
“Patients don’t die from PTMC, and most live longer than the age-matched population. Given the risks of more extensive surgery and our current data on surgical and patient-centered outcomes, I think that thyroid lobectomy should be the initial treatment for most patients with PTMC, and surgeons should help their patients make informed decisions,” Dr. Pitt said.
The National Institutes of Health provided funding. The researchers reported having no conflicts of interest.
Surgeons treated 95% of preoperatively diagnosed cases of papillary thyroid microcarcinoma with total thyroidectomy, compared with only 69% of postoperatively diagnosed cases, in to a single-center retrospective cohort study.
“During the study period, thyroid lobectomy was an acceptable alternative endorsed by the American Thyroid Association,” said Susan C. Pitt, MD, and her associates at the University of Wisconsin, Madison. “Nonetheless, documentation rarely stated that [thyroid lobectomy] was discussed as an option. Whether this finding indicates a true lack of discussion or a deficit in documentation is unclear, but emphasizes the need to improve the quality of the [electronic health record] and capture all elements of shared decision-making.”
Papillary thyroid microcarcinomas (PTMC) measure 1 cm or less, affect up to a third of adults, and explain about half of the recent rise in rates of papillary thyroid cancer, the investigators stated. Most cases are found incidentally and there is no evidence that they contribute to a rise in mortality, which stands at about 0.5 deaths per 100,000 diagnoses of thyroid carcinoma. Accordingly, in 2015, the American Thyroid Association (ATA) endorsed active surveillance and thyroid lobectomy as acceptable management strategies for most patients with PTMC (Thyroid. 2016 Jan 12;26[1]:1-133).
“The pendulum for the ATA guidelines has swung back and forth,” Dr. Pitt said in an interview. “I think the current 2015 ATA guidelines are still controversial – some surgeons and endocrinologists think we have swung too far [in the other direction]. Moving the field from total thyroidectomy to active surveillance is a big jump. Understanding the factors underlying current decisions will help us to implement less extensive management, like lobectomy and active surveillance.”
To do that, Dr. Pitt and her associates reviewed medical records from 125 patients with PTMC treated at the University of Wisconsin between 2008 and 2016. Most of the patients (90%) were white, 85% were female, average age was 50 years, and nearly all had classic or follicular-variant disease. Only 27% of patients underwent thyroid lobectomy; the rest underwent total thyroidectomy. Furthermore, among 19 patients diagnosed preoperatively, 95% underwent total thyroidectomy and 21% had a complication, including one (5%) case of permanent hypocalcemia that less extensive surgery might have avoided (J Surg Res. 2017;218:237-45).
“In all cases, documentation indicated that these preoperatively diagnosed patients followed the surgeon’s recommendation regarding the extent of surgery,” the researchers wrote. Surgeons cited various reasons for recommending total thyroidectomy, including – in about 20% of cases – a belief that it was the recommended treatment.
Only one of the 19 preoperatively diagnosed patients had a documented discussion of thyroid lobectomy, the researchers found.
While physicians might be concerned about recurrence or other “downstream” outcomes of a less-is-more approach to PTMC, Dr. Pitt noted that, in a recent large study, only 3.4% of these tumors metastasized over 10 years (World J Surg. 2010 Jan;34[1]:28-35).
“At the same time, I think that we have a better sense [that] patient-centered outcomes after thyroidectomy, such as health-related quality of life, swallowing, and voice outcomes, can be worse after a total thyroidectomy,” she added.
As surgical and medical therapies expand for PTMC and other nonmalignant diseases, it becomes increasingly vital that surgeons and patients undertake shared decision-making, she said. At the University of Wisconsin, physicians can enter free text in the EHR to document such discussions. She gave an example of how she does that: “‘Total thyroidectomy and lobectomy are both appropriate approaches for Ms. Smith. We discussed these options at length, including X, Y, and Z. Given Mrs. Smith’s (strong) preference to avoid X, we will proceed with a lobectomy.”
In her own practice, Dr. Pitt added, “when I look back at a note, I want to know what the decision was, and why it was made.”
Shared decision-making differs from informed consent by focusing on patient preferences, she noted. “I have used my notes in the operating room to help me decide what to do. I can look back and have a window into our conversation and what an individual patient values.” For PTMC, shared decisions should focus less on cancer risk and more on quality of life and outcomes a year later, she said.
“Patients don’t die from PTMC, and most live longer than the age-matched population. Given the risks of more extensive surgery and our current data on surgical and patient-centered outcomes, I think that thyroid lobectomy should be the initial treatment for most patients with PTMC, and surgeons should help their patients make informed decisions,” Dr. Pitt said.
The National Institutes of Health provided funding. The researchers reported having no conflicts of interest.
FROM THE JOURNAL OF SURGICAL RESEARCH
Key clinical point: Nearly all patients with a preoperative diagnosis of PTMC underwent total thyroidectomy, usually at their surgeon’s recommendation.
Major finding: 95% of preoperatively diagnosed patients underwent total thyroidectomy, versus 69% of those diagnosed postoperatively (P = .02). A discussion of thyroid lobectomy was documented in only one preoperatively diagnosed case.
Data source: A single-center retrospective study of 125 patients with papillary thyroid microcarcinoma.
Disclosures: The National Institutes of Health provided funding. The researchers reported having no conflicts of interest.
Reconstruction becoming more common after mastectomy
The rate of breast reconstruction surgery for mastectomy increased 62% from 2009 to 2014, while the mastectomy rate itself “remained relatively stable,” according to the Agency for Healthcare Research and Quality.
The rate of breast reconstructions in hospitals and ambulatory surgery settings rose steadily over the 6-year period, going from 21.7 per 100,000 women in 2009 to 35.1 per 100,000 in 2014. Meanwhile, the mastectomy rate dipped from 90.1 in 2009 to 83.2 in 2010 but varied less than 10% over the 2009-2014 time period, reaching 88.4 per 100,000 women in 2014. To put those numbers in a different context, the ratio of reconstructions to mastectomies went from 24-to-100 in 2009 to 40-to-100 in 2014, the AHRQ reported in a Statistical Brief.
Those nonsimultaneous procedures were taking place much more often in ambulatory settings by 2014, as the rate of reconstructions at a separate visit increased 152% from 7.4 per 100,000 women in 2009 to 18.2. Simultaneous reconstructions in ambulatory settings were less common but increased at an even greater rate of 155%, going from 1.1 to 2.8 per 100,000 women. Inpatient reconstruction had little or no growth over the 6 years: Separate-visit procedures went from 6 to 6.8 and simultaneous reconstructions actually dropped from 7.4 per 100,000 women to 7.3, they reported.
The analysis was based on data from AHRQ State Inpatient Databases and State Ambulatory Surgery and Services Databases for 22 states that include 59% of the U.S. population: California, Colorado, Connecticut, Florida, Georgia, Iowa, Indiana, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, South Carolina, South Dakota, Tennessee, Utah, Vermont, and Wisconsin.
The rate of breast reconstruction surgery for mastectomy increased 62% from 2009 to 2014, while the mastectomy rate itself “remained relatively stable,” according to the Agency for Healthcare Research and Quality.
The rate of breast reconstructions in hospitals and ambulatory surgery settings rose steadily over the 6-year period, going from 21.7 per 100,000 women in 2009 to 35.1 per 100,000 in 2014. Meanwhile, the mastectomy rate dipped from 90.1 in 2009 to 83.2 in 2010 but varied less than 10% over the 2009-2014 time period, reaching 88.4 per 100,000 women in 2014. To put those numbers in a different context, the ratio of reconstructions to mastectomies went from 24-to-100 in 2009 to 40-to-100 in 2014, the AHRQ reported in a Statistical Brief.
Those nonsimultaneous procedures were taking place much more often in ambulatory settings by 2014, as the rate of reconstructions at a separate visit increased 152% from 7.4 per 100,000 women in 2009 to 18.2. Simultaneous reconstructions in ambulatory settings were less common but increased at an even greater rate of 155%, going from 1.1 to 2.8 per 100,000 women. Inpatient reconstruction had little or no growth over the 6 years: Separate-visit procedures went from 6 to 6.8 and simultaneous reconstructions actually dropped from 7.4 per 100,000 women to 7.3, they reported.
The analysis was based on data from AHRQ State Inpatient Databases and State Ambulatory Surgery and Services Databases for 22 states that include 59% of the U.S. population: California, Colorado, Connecticut, Florida, Georgia, Iowa, Indiana, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, South Carolina, South Dakota, Tennessee, Utah, Vermont, and Wisconsin.
The rate of breast reconstruction surgery for mastectomy increased 62% from 2009 to 2014, while the mastectomy rate itself “remained relatively stable,” according to the Agency for Healthcare Research and Quality.
The rate of breast reconstructions in hospitals and ambulatory surgery settings rose steadily over the 6-year period, going from 21.7 per 100,000 women in 2009 to 35.1 per 100,000 in 2014. Meanwhile, the mastectomy rate dipped from 90.1 in 2009 to 83.2 in 2010 but varied less than 10% over the 2009-2014 time period, reaching 88.4 per 100,000 women in 2014. To put those numbers in a different context, the ratio of reconstructions to mastectomies went from 24-to-100 in 2009 to 40-to-100 in 2014, the AHRQ reported in a Statistical Brief.
Those nonsimultaneous procedures were taking place much more often in ambulatory settings by 2014, as the rate of reconstructions at a separate visit increased 152% from 7.4 per 100,000 women in 2009 to 18.2. Simultaneous reconstructions in ambulatory settings were less common but increased at an even greater rate of 155%, going from 1.1 to 2.8 per 100,000 women. Inpatient reconstruction had little or no growth over the 6 years: Separate-visit procedures went from 6 to 6.8 and simultaneous reconstructions actually dropped from 7.4 per 100,000 women to 7.3, they reported.
The analysis was based on data from AHRQ State Inpatient Databases and State Ambulatory Surgery and Services Databases for 22 states that include 59% of the U.S. population: California, Colorado, Connecticut, Florida, Georgia, Iowa, Indiana, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, South Carolina, South Dakota, Tennessee, Utah, Vermont, and Wisconsin.
Many new cancer drugs lack evidence of survival or QoL benefit
Even after several years on the market, only about half of cancer drug indications recently approved by the European Medicines Agency (EMA) had conclusive evidence that they can extend or improve quality of life, according to results of a retrospective cohort study.
With a median of 5.4 years of follow-up, significant improvements in overall survival or quality of life had been published for 35 of 68 (51%) cancer drug indications approved by the EMA, according to the report by Courtney Davis, MD, senior lecturer in the department of global health and social medicine, King’s College London, United Kingdom, and colleagues.
Furthermore, not all survival benefits were clinically meaningful, according to an analysis published in the report.
The dearth of evidence for survival or quality-of-life benefits has “negative implications” for both patients and public health, Dr. Davis and colleagues said in their article (BMJ 2017 Oct 5. doi:10.1136/bmj.j4530).
“When expensive drugs that lack clinically meaningful benefits are approved and paid for within publicly funded healthcare systems, individual patients can be harmed, important societal resources wasted, and the delivery of equitable and affordable care undermined,” they wrote.
Dr. Davis and associates systematically evaluated the evidence base for regulatory and scientific reports on 48 cancer drugs approved for 68 indications by the EMA between 2009-2013. Of those indications, 17 were for hematologic malignancies and 51 were for solid tumors.
Only 18 of 68 indications (26%) were supported by pivotal studies that had a primary outcome of overall survival, according to the investigators. That was an important finding for the investigators, who wrote that that EMA commonly accepts use of surrogate measures of drug benefit despite their own statements that overall survival is the “most persuasive outcome” in studies of new oncology drugs.
“To a large extent, regulatory evidence standards determine the clinical value of … new oncology drugs,” Dr. Davis and co-authors wrote. “Our study suggests these standards are failing to incentivize drug development that best meets the needs of patients, clinicians, and healthcare systems.”
The investigators also assessed the clinical value of reported improvements using the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS). According to investigators, only 11 of the 23 drugs used to treat solid tumors (48%) reached the threshold for a meaningful survival benefit.
This report in BMJ echoes findings of an earlier study by Chul Kim, MD, and colleagues looking at cancer drugs approved by the U.S. Food and Drug Administration (FDA) between 2008 and 2012 (JAMA Intern Med. 2015;175(12):1992-4).
Dr. Kim, of the medical oncology service, National Cancer Institute, National Institutes of Health, Bethesda, Md., and colleagues found that 36 of 54 FDA approvals (67%) occurred with no evidence of survival or quality of life benefit. After a median of 4.4 years of follow-up, only 5 of those 36 (14%) had additional randomized study data that showed an improvement in overall survival, according to the published report.
The study was supported by Health Action International, which did not have a role in study design or data collection, analysis, or interpretation. The authors did not give financial disclosures.
The expense and toxicity of cancer drugs mean we have an obligation to expose patients to treatment only when they can reasonably expect an improvement in survival or quality of life. The study by Davis and colleagues suggests we may be falling far short of this important benchmark.
Few cancer drugs come to market with good evidence that they improve patient centered outcomes. If they do, they often offer marginal benefits that may be lost in the heterogeneous patients of the real world. Most approvals of cancer drugs are based on flimsy or untested surrogate endpoints, and postmarketing studies rarely validate the efficacy and safety of these drugs on patient centered endpoints.
In the United States, this broken system means huge expenditures on cancer drugs with certain toxicity but uncertain benefit. In Europe, payers yield the stick left unused by lax regulatoers. The National Institute for Health and Care Excellence (NICE) excludes from reimbursement drugs that provide only marginal or uncertain benefits at high cost. Their decisions are continually subjected to political scrutiny and public criticism.
What can be done? The default path to market for all cancer drugs should include rigorous testing against the best standard of care in randomized trials powered to rule in or rule out a clinically meaningful difference in patient centered outcomes in a representative population. The use of uncontrolled study designs or surrogate endpoints should be the exception, not the rule.
Vinay Prasad, MD, MPH, is assistant professor of medicine at Oregon Health and Science University, Portland. He declared a competing interest (royalties from his book Ending Medical Reversal). These comments are from his editorial (BMJ 2017 Oct 5. doi: 10.1136/bmj.j4528 )
The expense and toxicity of cancer drugs mean we have an obligation to expose patients to treatment only when they can reasonably expect an improvement in survival or quality of life. The study by Davis and colleagues suggests we may be falling far short of this important benchmark.
Few cancer drugs come to market with good evidence that they improve patient centered outcomes. If they do, they often offer marginal benefits that may be lost in the heterogeneous patients of the real world. Most approvals of cancer drugs are based on flimsy or untested surrogate endpoints, and postmarketing studies rarely validate the efficacy and safety of these drugs on patient centered endpoints.
In the United States, this broken system means huge expenditures on cancer drugs with certain toxicity but uncertain benefit. In Europe, payers yield the stick left unused by lax regulatoers. The National Institute for Health and Care Excellence (NICE) excludes from reimbursement drugs that provide only marginal or uncertain benefits at high cost. Their decisions are continually subjected to political scrutiny and public criticism.
What can be done? The default path to market for all cancer drugs should include rigorous testing against the best standard of care in randomized trials powered to rule in or rule out a clinically meaningful difference in patient centered outcomes in a representative population. The use of uncontrolled study designs or surrogate endpoints should be the exception, not the rule.
Vinay Prasad, MD, MPH, is assistant professor of medicine at Oregon Health and Science University, Portland. He declared a competing interest (royalties from his book Ending Medical Reversal). These comments are from his editorial (BMJ 2017 Oct 5. doi: 10.1136/bmj.j4528 )
The expense and toxicity of cancer drugs mean we have an obligation to expose patients to treatment only when they can reasonably expect an improvement in survival or quality of life. The study by Davis and colleagues suggests we may be falling far short of this important benchmark.
Few cancer drugs come to market with good evidence that they improve patient centered outcomes. If they do, they often offer marginal benefits that may be lost in the heterogeneous patients of the real world. Most approvals of cancer drugs are based on flimsy or untested surrogate endpoints, and postmarketing studies rarely validate the efficacy and safety of these drugs on patient centered endpoints.
In the United States, this broken system means huge expenditures on cancer drugs with certain toxicity but uncertain benefit. In Europe, payers yield the stick left unused by lax regulatoers. The National Institute for Health and Care Excellence (NICE) excludes from reimbursement drugs that provide only marginal or uncertain benefits at high cost. Their decisions are continually subjected to political scrutiny and public criticism.
What can be done? The default path to market for all cancer drugs should include rigorous testing against the best standard of care in randomized trials powered to rule in or rule out a clinically meaningful difference in patient centered outcomes in a representative population. The use of uncontrolled study designs or surrogate endpoints should be the exception, not the rule.
Vinay Prasad, MD, MPH, is assistant professor of medicine at Oregon Health and Science University, Portland. He declared a competing interest (royalties from his book Ending Medical Reversal). These comments are from his editorial (BMJ 2017 Oct 5. doi: 10.1136/bmj.j4528 )
Even after several years on the market, only about half of cancer drug indications recently approved by the European Medicines Agency (EMA) had conclusive evidence that they can extend or improve quality of life, according to results of a retrospective cohort study.
With a median of 5.4 years of follow-up, significant improvements in overall survival or quality of life had been published for 35 of 68 (51%) cancer drug indications approved by the EMA, according to the report by Courtney Davis, MD, senior lecturer in the department of global health and social medicine, King’s College London, United Kingdom, and colleagues.
Furthermore, not all survival benefits were clinically meaningful, according to an analysis published in the report.
The dearth of evidence for survival or quality-of-life benefits has “negative implications” for both patients and public health, Dr. Davis and colleagues said in their article (BMJ 2017 Oct 5. doi:10.1136/bmj.j4530).
“When expensive drugs that lack clinically meaningful benefits are approved and paid for within publicly funded healthcare systems, individual patients can be harmed, important societal resources wasted, and the delivery of equitable and affordable care undermined,” they wrote.
Dr. Davis and associates systematically evaluated the evidence base for regulatory and scientific reports on 48 cancer drugs approved for 68 indications by the EMA between 2009-2013. Of those indications, 17 were for hematologic malignancies and 51 were for solid tumors.
Only 18 of 68 indications (26%) were supported by pivotal studies that had a primary outcome of overall survival, according to the investigators. That was an important finding for the investigators, who wrote that that EMA commonly accepts use of surrogate measures of drug benefit despite their own statements that overall survival is the “most persuasive outcome” in studies of new oncology drugs.
“To a large extent, regulatory evidence standards determine the clinical value of … new oncology drugs,” Dr. Davis and co-authors wrote. “Our study suggests these standards are failing to incentivize drug development that best meets the needs of patients, clinicians, and healthcare systems.”
The investigators also assessed the clinical value of reported improvements using the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS). According to investigators, only 11 of the 23 drugs used to treat solid tumors (48%) reached the threshold for a meaningful survival benefit.
This report in BMJ echoes findings of an earlier study by Chul Kim, MD, and colleagues looking at cancer drugs approved by the U.S. Food and Drug Administration (FDA) between 2008 and 2012 (JAMA Intern Med. 2015;175(12):1992-4).
Dr. Kim, of the medical oncology service, National Cancer Institute, National Institutes of Health, Bethesda, Md., and colleagues found that 36 of 54 FDA approvals (67%) occurred with no evidence of survival or quality of life benefit. After a median of 4.4 years of follow-up, only 5 of those 36 (14%) had additional randomized study data that showed an improvement in overall survival, according to the published report.
The study was supported by Health Action International, which did not have a role in study design or data collection, analysis, or interpretation. The authors did not give financial disclosures.
Even after several years on the market, only about half of cancer drug indications recently approved by the European Medicines Agency (EMA) had conclusive evidence that they can extend or improve quality of life, according to results of a retrospective cohort study.
With a median of 5.4 years of follow-up, significant improvements in overall survival or quality of life had been published for 35 of 68 (51%) cancer drug indications approved by the EMA, according to the report by Courtney Davis, MD, senior lecturer in the department of global health and social medicine, King’s College London, United Kingdom, and colleagues.
Furthermore, not all survival benefits were clinically meaningful, according to an analysis published in the report.
The dearth of evidence for survival or quality-of-life benefits has “negative implications” for both patients and public health, Dr. Davis and colleagues said in their article (BMJ 2017 Oct 5. doi:10.1136/bmj.j4530).
“When expensive drugs that lack clinically meaningful benefits are approved and paid for within publicly funded healthcare systems, individual patients can be harmed, important societal resources wasted, and the delivery of equitable and affordable care undermined,” they wrote.
Dr. Davis and associates systematically evaluated the evidence base for regulatory and scientific reports on 48 cancer drugs approved for 68 indications by the EMA between 2009-2013. Of those indications, 17 were for hematologic malignancies and 51 were for solid tumors.
Only 18 of 68 indications (26%) were supported by pivotal studies that had a primary outcome of overall survival, according to the investigators. That was an important finding for the investigators, who wrote that that EMA commonly accepts use of surrogate measures of drug benefit despite their own statements that overall survival is the “most persuasive outcome” in studies of new oncology drugs.
“To a large extent, regulatory evidence standards determine the clinical value of … new oncology drugs,” Dr. Davis and co-authors wrote. “Our study suggests these standards are failing to incentivize drug development that best meets the needs of patients, clinicians, and healthcare systems.”
The investigators also assessed the clinical value of reported improvements using the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS). According to investigators, only 11 of the 23 drugs used to treat solid tumors (48%) reached the threshold for a meaningful survival benefit.
This report in BMJ echoes findings of an earlier study by Chul Kim, MD, and colleagues looking at cancer drugs approved by the U.S. Food and Drug Administration (FDA) between 2008 and 2012 (JAMA Intern Med. 2015;175(12):1992-4).
Dr. Kim, of the medical oncology service, National Cancer Institute, National Institutes of Health, Bethesda, Md., and colleagues found that 36 of 54 FDA approvals (67%) occurred with no evidence of survival or quality of life benefit. After a median of 4.4 years of follow-up, only 5 of those 36 (14%) had additional randomized study data that showed an improvement in overall survival, according to the published report.
The study was supported by Health Action International, which did not have a role in study design or data collection, analysis, or interpretation. The authors did not give financial disclosures.
From BMJ
Key clinical point: Even after several years on the market, only about half of cancer drug indications recently approved by the European Medicines Agency (EMA) lacked conclusive evidence that they can extend or improve quality of life.
Major finding: With a median of 5.4 years of follow-up, significant improvements in overall survival or quality of life had been published for 35 of 68 (51%) cancer drug indications approved by the EMA.
Data source: Retrospective cohort study of regulatory and scientific reports on 48 cancer drugs approved for 68 indications by the EMA between 2009-2013.
Disclosures: The study was supported by Health Action International, which did not have a role in study design or data collection, analysis, or interpretation.
Robot-assisted abdominoperineal resection outperforms open or laparoscopic surgery for rectal cancers
MADRID – The automaton uprising continues: Robot-assisted abdominoperineal resection (APR) can be safely performed in patients with rectal cancers within 5 cm of the anal verge, with surgical results equivalent to those seen with open or laparoscopic APR, investigators say.
Robot-assisted procedures were associated with a significantly lower rate of postoperative complications and with faster functional recovery than either laparoscopic or open surgery in a randomized trial, reported Jianmin Xu, MD, PhD., from Fudan University in Shanghai, China, and colleagues in a scientific poster presented at the European Society for Medical Oncology Congress.
“Retrospective studies have showed that robotic surgery was better than laparoscopic surgery in ensuring radical resection, reducing complications, and promoting recovery. However, there is no clinical trial reported for robotic surgery for rectal cancer. Thus, we conduct this randomized controlled trial to compare the safety and efficacy of robotic, laparoscopic, and open surgery for low rectal cancer,” they wrote.
Dr. Xu and colleagues enrolled 506 patients from 18 to 75 years of age with clinical stage T1 to T3 cancers within 5 cm of the anal verge and no distant metastases and randomly assigned them to resection with either a robot-assisted, laparoscopic, or open APR technique. Three of the 506 patients randomized did not undergo resection, leaving 503 for the per-protocol analysis presented here.
For the primary endpoint of complications rates within 30 days following surgery, the investigators found that patients assigned to robotic-assisted surgery (173 patients) had a total complication rate of 10.4%, compared with 18.8% for 176 patients assigned to laparoscopy (P = .027), and 26% for 154 assigned to open APR (P less than .001). The latter group included four patients assigned to laparoscopy whose procedures were converted to open surgery.
Among patients without complications, robot-assisted procedures were also associated with faster recovery, as measured by days to first flatus, at a median of 1 vs. 2 for laparoscopy and 3 for open procedures (P less than .001 for robots vs. each other surgery type). The robotic surgery was also significantly associated with fewer days to first automatic urination (median 2 vs. 4 for each of the other procedures; P less than .001), and with fewer days to discharge (median 5 vs. 7 for the other procedures; P less than .001).
"These are excellent postoperative complication rates reported, especially for the robotic treatment group, commented Thomas Gruenberger, MD, an oncologic surgeon at Rudolf Hospital in Vienna, in a poster discussion session.
“We all are now favoring laparoscopic surgery for these kinds of patients. The robot is a nice thing to have; however, we cannot use it in every hospital because it’s still quite expensive,” he said.
“We require – and this is a secondary endpoint of the study – long-term follow-up for local and distant outcomes,” he added,
The investigators did not report a funding source. All authors declared having no conflicts of interest. Dr. Gruenberger disclosed research funding, speakers bureau participation, and/or advisory roles with several companies.
MADRID – The automaton uprising continues: Robot-assisted abdominoperineal resection (APR) can be safely performed in patients with rectal cancers within 5 cm of the anal verge, with surgical results equivalent to those seen with open or laparoscopic APR, investigators say.
Robot-assisted procedures were associated with a significantly lower rate of postoperative complications and with faster functional recovery than either laparoscopic or open surgery in a randomized trial, reported Jianmin Xu, MD, PhD., from Fudan University in Shanghai, China, and colleagues in a scientific poster presented at the European Society for Medical Oncology Congress.
“Retrospective studies have showed that robotic surgery was better than laparoscopic surgery in ensuring radical resection, reducing complications, and promoting recovery. However, there is no clinical trial reported for robotic surgery for rectal cancer. Thus, we conduct this randomized controlled trial to compare the safety and efficacy of robotic, laparoscopic, and open surgery for low rectal cancer,” they wrote.
Dr. Xu and colleagues enrolled 506 patients from 18 to 75 years of age with clinical stage T1 to T3 cancers within 5 cm of the anal verge and no distant metastases and randomly assigned them to resection with either a robot-assisted, laparoscopic, or open APR technique. Three of the 506 patients randomized did not undergo resection, leaving 503 for the per-protocol analysis presented here.
For the primary endpoint of complications rates within 30 days following surgery, the investigators found that patients assigned to robotic-assisted surgery (173 patients) had a total complication rate of 10.4%, compared with 18.8% for 176 patients assigned to laparoscopy (P = .027), and 26% for 154 assigned to open APR (P less than .001). The latter group included four patients assigned to laparoscopy whose procedures were converted to open surgery.
Among patients without complications, robot-assisted procedures were also associated with faster recovery, as measured by days to first flatus, at a median of 1 vs. 2 for laparoscopy and 3 for open procedures (P less than .001 for robots vs. each other surgery type). The robotic surgery was also significantly associated with fewer days to first automatic urination (median 2 vs. 4 for each of the other procedures; P less than .001), and with fewer days to discharge (median 5 vs. 7 for the other procedures; P less than .001).
"These are excellent postoperative complication rates reported, especially for the robotic treatment group, commented Thomas Gruenberger, MD, an oncologic surgeon at Rudolf Hospital in Vienna, in a poster discussion session.
“We all are now favoring laparoscopic surgery for these kinds of patients. The robot is a nice thing to have; however, we cannot use it in every hospital because it’s still quite expensive,” he said.
“We require – and this is a secondary endpoint of the study – long-term follow-up for local and distant outcomes,” he added,
The investigators did not report a funding source. All authors declared having no conflicts of interest. Dr. Gruenberger disclosed research funding, speakers bureau participation, and/or advisory roles with several companies.
MADRID – The automaton uprising continues: Robot-assisted abdominoperineal resection (APR) can be safely performed in patients with rectal cancers within 5 cm of the anal verge, with surgical results equivalent to those seen with open or laparoscopic APR, investigators say.
Robot-assisted procedures were associated with a significantly lower rate of postoperative complications and with faster functional recovery than either laparoscopic or open surgery in a randomized trial, reported Jianmin Xu, MD, PhD., from Fudan University in Shanghai, China, and colleagues in a scientific poster presented at the European Society for Medical Oncology Congress.
“Retrospective studies have showed that robotic surgery was better than laparoscopic surgery in ensuring radical resection, reducing complications, and promoting recovery. However, there is no clinical trial reported for robotic surgery for rectal cancer. Thus, we conduct this randomized controlled trial to compare the safety and efficacy of robotic, laparoscopic, and open surgery for low rectal cancer,” they wrote.
Dr. Xu and colleagues enrolled 506 patients from 18 to 75 years of age with clinical stage T1 to T3 cancers within 5 cm of the anal verge and no distant metastases and randomly assigned them to resection with either a robot-assisted, laparoscopic, or open APR technique. Three of the 506 patients randomized did not undergo resection, leaving 503 for the per-protocol analysis presented here.
For the primary endpoint of complications rates within 30 days following surgery, the investigators found that patients assigned to robotic-assisted surgery (173 patients) had a total complication rate of 10.4%, compared with 18.8% for 176 patients assigned to laparoscopy (P = .027), and 26% for 154 assigned to open APR (P less than .001). The latter group included four patients assigned to laparoscopy whose procedures were converted to open surgery.
Among patients without complications, robot-assisted procedures were also associated with faster recovery, as measured by days to first flatus, at a median of 1 vs. 2 for laparoscopy and 3 for open procedures (P less than .001 for robots vs. each other surgery type). The robotic surgery was also significantly associated with fewer days to first automatic urination (median 2 vs. 4 for each of the other procedures; P less than .001), and with fewer days to discharge (median 5 vs. 7 for the other procedures; P less than .001).
"These are excellent postoperative complication rates reported, especially for the robotic treatment group, commented Thomas Gruenberger, MD, an oncologic surgeon at Rudolf Hospital in Vienna, in a poster discussion session.
“We all are now favoring laparoscopic surgery for these kinds of patients. The robot is a nice thing to have; however, we cannot use it in every hospital because it’s still quite expensive,” he said.
“We require – and this is a secondary endpoint of the study – long-term follow-up for local and distant outcomes,” he added,
The investigators did not report a funding source. All authors declared having no conflicts of interest. Dr. Gruenberger disclosed research funding, speakers bureau participation, and/or advisory roles with several companies.
AT ESMO 2017
Transoral robotic surgery assessed for oral lesions
A single-arm study is being conducted at the Ohio State University Comprehensive Cancer Center, Columbus, to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the da Vinci Robotic Surgical System.
The study started in 2007, and the estimated completion date is December 2020. Investigators hope to enroll 360 adults.
Patients are scheduled for regular postop visits to assess quality of life and other matters. Those unable to return to Ohio State University are contacted by phone or provided with the questionnaire by mail.
A single-arm study is being conducted at the Ohio State University Comprehensive Cancer Center, Columbus, to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the da Vinci Robotic Surgical System.
The study started in 2007, and the estimated completion date is December 2020. Investigators hope to enroll 360 adults.
Patients are scheduled for regular postop visits to assess quality of life and other matters. Those unable to return to Ohio State University are contacted by phone or provided with the questionnaire by mail.
A single-arm study is being conducted at the Ohio State University Comprehensive Cancer Center, Columbus, to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the da Vinci Robotic Surgical System.
The study started in 2007, and the estimated completion date is December 2020. Investigators hope to enroll 360 adults.
Patients are scheduled for regular postop visits to assess quality of life and other matters. Those unable to return to Ohio State University are contacted by phone or provided with the questionnaire by mail.
Robot-assisted prostatectomy providing better outcomes
Robot-assisted radical prostatectomy shows better early postoperative outcomes than does laparoscopic radical prostatectomy, but the differences between the two surgical approaches disappeared by the 6-month follow-up.
Dr. Hiroyuki Koike and his colleagues at Wakayama (Japan) Medical University Hospital conducted a study of two groups of patients treated for localized prostate cancer. One group of 229 patients underwent laparoscopic radical prostatectomy (LRP) between July 2007 and July 2013. The other group of 115 patients had robot-assisted radical prostatectomy (RARP) between December 2012 and August 2014 (J Robot Surg. 2017;11[3]:325-31).
The patients were given health-related quality of life self-assessment surveys prior to surgery and at 3, 6, and 12 months post surgery. In addition, a generic questionnaire, the eight-item Short-Form Health Survey, was used to assess a physical component summary (PCS) and a mental component summary (MCS). The Expanded Prostate Cancer Index of Prostate, which covers four domains – urinary, sexual, bowel, and hormonal – was used as a disease-specific measure, and the response rates for both LRP and RARP at each follow-up interval were over 80%.
“The RARP group showed significantly better scores in urinary summary and all urinary subscales at postoperative 3-month follow-up. However, these differences disappeared at postoperative 6 and 12-month follow-up,” the investigators wrote. For the urinary summary score, LRP significantly underperformed, compared with RARP, with scores of 63.3 vs. 75.8, respectively, after 3 months. In addition, the bowel function score was superior for RARP, compared with LRP, at 96.9 vs. 92.9, respectively. Sexual function results were similar, with RARP and LRP scores of 2.8 vs. 0.
The general measures of the PCS and MCS also favored RARP. At the 3-month follow-up, PCS (51.3 vs. 48.1) and MCS (50 vs. 47.8) scores were higher for RARP, compared with LRP.
“It is unclear why our superiority of urinary function in RARP was observed only in early period. However, we can speculate several reasons for better urinary function in RARP group. First, we were able to treat the apex area more delicately with RARP. Second, some of the new techniques which we employed after the introduction of RARP could influence the urinary continence recovery,” the investigators wrote.
The authors had no relevant financial disclosures.
Robot-assisted radical prostatectomy shows better early postoperative outcomes than does laparoscopic radical prostatectomy, but the differences between the two surgical approaches disappeared by the 6-month follow-up.
Dr. Hiroyuki Koike and his colleagues at Wakayama (Japan) Medical University Hospital conducted a study of two groups of patients treated for localized prostate cancer. One group of 229 patients underwent laparoscopic radical prostatectomy (LRP) between July 2007 and July 2013. The other group of 115 patients had robot-assisted radical prostatectomy (RARP) between December 2012 and August 2014 (J Robot Surg. 2017;11[3]:325-31).
The patients were given health-related quality of life self-assessment surveys prior to surgery and at 3, 6, and 12 months post surgery. In addition, a generic questionnaire, the eight-item Short-Form Health Survey, was used to assess a physical component summary (PCS) and a mental component summary (MCS). The Expanded Prostate Cancer Index of Prostate, which covers four domains – urinary, sexual, bowel, and hormonal – was used as a disease-specific measure, and the response rates for both LRP and RARP at each follow-up interval were over 80%.
“The RARP group showed significantly better scores in urinary summary and all urinary subscales at postoperative 3-month follow-up. However, these differences disappeared at postoperative 6 and 12-month follow-up,” the investigators wrote. For the urinary summary score, LRP significantly underperformed, compared with RARP, with scores of 63.3 vs. 75.8, respectively, after 3 months. In addition, the bowel function score was superior for RARP, compared with LRP, at 96.9 vs. 92.9, respectively. Sexual function results were similar, with RARP and LRP scores of 2.8 vs. 0.
The general measures of the PCS and MCS also favored RARP. At the 3-month follow-up, PCS (51.3 vs. 48.1) and MCS (50 vs. 47.8) scores were higher for RARP, compared with LRP.
“It is unclear why our superiority of urinary function in RARP was observed only in early period. However, we can speculate several reasons for better urinary function in RARP group. First, we were able to treat the apex area more delicately with RARP. Second, some of the new techniques which we employed after the introduction of RARP could influence the urinary continence recovery,” the investigators wrote.
The authors had no relevant financial disclosures.
Robot-assisted radical prostatectomy shows better early postoperative outcomes than does laparoscopic radical prostatectomy, but the differences between the two surgical approaches disappeared by the 6-month follow-up.
Dr. Hiroyuki Koike and his colleagues at Wakayama (Japan) Medical University Hospital conducted a study of two groups of patients treated for localized prostate cancer. One group of 229 patients underwent laparoscopic radical prostatectomy (LRP) between July 2007 and July 2013. The other group of 115 patients had robot-assisted radical prostatectomy (RARP) between December 2012 and August 2014 (J Robot Surg. 2017;11[3]:325-31).
The patients were given health-related quality of life self-assessment surveys prior to surgery and at 3, 6, and 12 months post surgery. In addition, a generic questionnaire, the eight-item Short-Form Health Survey, was used to assess a physical component summary (PCS) and a mental component summary (MCS). The Expanded Prostate Cancer Index of Prostate, which covers four domains – urinary, sexual, bowel, and hormonal – was used as a disease-specific measure, and the response rates for both LRP and RARP at each follow-up interval were over 80%.
“The RARP group showed significantly better scores in urinary summary and all urinary subscales at postoperative 3-month follow-up. However, these differences disappeared at postoperative 6 and 12-month follow-up,” the investigators wrote. For the urinary summary score, LRP significantly underperformed, compared with RARP, with scores of 63.3 vs. 75.8, respectively, after 3 months. In addition, the bowel function score was superior for RARP, compared with LRP, at 96.9 vs. 92.9, respectively. Sexual function results were similar, with RARP and LRP scores of 2.8 vs. 0.
The general measures of the PCS and MCS also favored RARP. At the 3-month follow-up, PCS (51.3 vs. 48.1) and MCS (50 vs. 47.8) scores were higher for RARP, compared with LRP.
“It is unclear why our superiority of urinary function in RARP was observed only in early period. However, we can speculate several reasons for better urinary function in RARP group. First, we were able to treat the apex area more delicately with RARP. Second, some of the new techniques which we employed after the introduction of RARP could influence the urinary continence recovery,” the investigators wrote.
The authors had no relevant financial disclosures.
FROM JOURNAL OF ROBOTIC SURGERY
Key clinical point:
Major finding: Quality-of-life score for robotic-assisted radical prostatectomy was higher in all urinary categories after 3 months.
Data source: Postop survey results from patients with localized prostate cancer who underwent laparoscopic radical prostatectomy (n = 229) or robot-assisted radical prostatectomy (n = 115).
Disclosures: The investigators had no financial disclosures to report.
Consider adding chemotherapy after GI surgery
Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.
Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).
The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.
The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.
The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.
However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.
The researchers had no financial conflicts to disclose.
The study findings “seem to indicate that additional systemic chemotherapy could be advantageous for patients treated with neoadjuvant chemoradiotherapy for resectable gastroesophageal cancer,” wrote David Cunningham, MD, FMedSci, and Elizabeth C. Smyth, MB, BCh., MSc., in an accompanying editorial.
“The small percentage of patients treated with adjuvant chemotherapy is reassuring; neoadjuvant chemoradiotherapy and surgery followed by adjuvant chemotherapy is not a treatment approach endorsed by current national or international guidelines,” they noted. The findings suggest that the 4% increase in overall survival at 3 years is promising because most gastroesophageal cancer recurrences arise within 3 years of surgery, they said. “However, these results require validation in the form of a randomized clinical trial,” they emphasized (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2792).
Dr. Cunningham and Ms. Smyth are affiliated with the department of gastrointestinal oncology and lymphoma at the Royal Marsden Hospital, London. Dr. Cunningham disclosed institutional research funding from Amgen, AstraZeneca, Bayer, Celgene, MedImmune, Merck Serono, Merrimack, and Sanofi. Ms. Smyth disclosed honoraria for advisory roles with Five Prime Therapeutics, Bristol-Myers Squibb, and Gritstone Oncology.
The study findings “seem to indicate that additional systemic chemotherapy could be advantageous for patients treated with neoadjuvant chemoradiotherapy for resectable gastroesophageal cancer,” wrote David Cunningham, MD, FMedSci, and Elizabeth C. Smyth, MB, BCh., MSc., in an accompanying editorial.
“The small percentage of patients treated with adjuvant chemotherapy is reassuring; neoadjuvant chemoradiotherapy and surgery followed by adjuvant chemotherapy is not a treatment approach endorsed by current national or international guidelines,” they noted. The findings suggest that the 4% increase in overall survival at 3 years is promising because most gastroesophageal cancer recurrences arise within 3 years of surgery, they said. “However, these results require validation in the form of a randomized clinical trial,” they emphasized (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2792).
Dr. Cunningham and Ms. Smyth are affiliated with the department of gastrointestinal oncology and lymphoma at the Royal Marsden Hospital, London. Dr. Cunningham disclosed institutional research funding from Amgen, AstraZeneca, Bayer, Celgene, MedImmune, Merck Serono, Merrimack, and Sanofi. Ms. Smyth disclosed honoraria for advisory roles with Five Prime Therapeutics, Bristol-Myers Squibb, and Gritstone Oncology.
The study findings “seem to indicate that additional systemic chemotherapy could be advantageous for patients treated with neoadjuvant chemoradiotherapy for resectable gastroesophageal cancer,” wrote David Cunningham, MD, FMedSci, and Elizabeth C. Smyth, MB, BCh., MSc., in an accompanying editorial.
“The small percentage of patients treated with adjuvant chemotherapy is reassuring; neoadjuvant chemoradiotherapy and surgery followed by adjuvant chemotherapy is not a treatment approach endorsed by current national or international guidelines,” they noted. The findings suggest that the 4% increase in overall survival at 3 years is promising because most gastroesophageal cancer recurrences arise within 3 years of surgery, they said. “However, these results require validation in the form of a randomized clinical trial,” they emphasized (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2792).
Dr. Cunningham and Ms. Smyth are affiliated with the department of gastrointestinal oncology and lymphoma at the Royal Marsden Hospital, London. Dr. Cunningham disclosed institutional research funding from Amgen, AstraZeneca, Bayer, Celgene, MedImmune, Merck Serono, Merrimack, and Sanofi. Ms. Smyth disclosed honoraria for advisory roles with Five Prime Therapeutics, Bristol-Myers Squibb, and Gritstone Oncology.
Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.
Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).
The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.
The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.
The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.
However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.
The researchers had no financial conflicts to disclose.
Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.
Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).
The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.
The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.
The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.
However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.
The researchers had no financial conflicts to disclose.
FROM JAMA ONCOLOGY
Key clinical point: Patients undergoing surgery for gastroesophageal cancer may benefit from additional chemotherapy.
Major finding: Overall survival rates improved in patients who received adjuvant chemotherapy, compared with those who did not (40 months vs. 34 months, respectively).
Data source: A review of 10,086 adults in the National Cancer Database who underwent gastroesophageal cancer surgery during 2006-2013.
Disclosures: The researchers had no financial conflicts to disclose.