ASTRO Annual Meeting 2013

ATLANTA – A decade after treatment for early-stage breast cancer, women who underwent surgery and radiation had higher survival rates than women who had surgery alone, with no increase in radiation-related cardiac or secondary cancer deaths, investigators reported at the annual meeting of the American Society for Radiation Oncology.

An analysis of Surveillance, Epidemiology and End Results (SEER) data on women treated for stage TIA N0 breast cancer in their mid to late 50s showed that after a median follow-up of 14 years, 10-year overall survival among the 2,397 women who received lumpectomy or mastectomy and radiation was 91.6%, compared with 87% for 2,988 women who had lumpectomy or mastectomy only (P less than .001).

Ten-year cardiac cause–specific survival was 96.7% vs. 92.7% (P less than .001), respectively. Breast cancer–specific survival was also higher among women who had undergone radiation, at 97% vs. 95.7% (P = .01), reported Dr. Jason C. Ye, a resident in radiation oncology at Weill Cornell Medical College, New York.

The data also suggest that breast irradiation does not increase the risk of lung cancer death, which occurred in 6 patients (1.9%) who underwent lumpectomy and radiation, and in 48 (1.6%) of those who had lumpectomies only, a difference that was not significant.

Dr. Ye noted, however, that between-group differences may begin to show up with longer follow-up.

"Although 14 years is a long time, studies have found increases in cardiac mortality and secondary cancers at 20 and 30 years after radiation. Also, there might have been a selection bias by physicians treating at the time, based on patients’ comorbidities and the patient’s health status. This might explain why the overall survival and the cardiac cause–specific survival were different between the two groups, with the no-radiation arm doing worse," he said at a media briefing.

In addition, changes in techniques introduced since the 1990s, such as three-dimensional conformal radiation, prone irradiation, hypofractionation, and intensity-modulated radiation therapy, may have effects on cardiac-specific and overall survival rates in the future, Dr. Ye said.

Dr. Ye and his colleagues reviewed SEER records on 5,385 women treated for early breast cancer during 1990-1997, and stratified them according to treatment with external-beam radiation or no radiation.

They included only patients with stage TIA N0 breast cancer identified as their first malignancy.

The authors used cause-of-death codes to identify cardiac deaths (either from cardiac disease or from atherosclerosis, breast cancer mortality, and deaths from second cancers in the chest area).

Radiation was associated with significantly lower overall mortality (relative risk, 0.69; P less than .001), breast cancer mortality (RR, 0.75; P = .02), and cardiac mortality (RR, 0.53; P less than .001).

Women with tumors in the left breast, whose hearts would presumably receive a larger dose of radiation than women with right breast tumors, were not at increased risk for cardiac-specific death. Deaths from second cancers included lung cancer in 2%; lymphomas and leukemias, each in 0.4%; soft-tissue malignancies (including the heart) in 0.06%; and cancer of the esophagus in 0.04%.

There were no significant differences between the radiation and no-radiation groups in incidence of death from second cancers.

The study was supported by the National Cancer Institute. Dr. Ye reported having no relevant disclosures.

ATLANTA – A decade after treatment for early-stage breast cancer, women who underwent surgery and radiation had higher survival rates than women who had surgery alone, with no increase in radiation-related cardiac or secondary cancer deaths, investigators reported at the annual meeting of the American Society for Radiation Oncology.

An analysis of Surveillance, Epidemiology and End Results (SEER) data on women treated for stage TIA N0 breast cancer in their mid to late 50s showed that after a median follow-up of 14 years, 10-year overall survival among the 2,397 women who received lumpectomy or mastectomy and radiation was 91.6%, compared with 87% for 2,988 women who had lumpectomy or mastectomy only (P less than .001).

Ten-year cardiac cause–specific survival was 96.7% vs. 92.7% (P less than .001), respectively. Breast cancer–specific survival was also higher among women who had undergone radiation, at 97% vs. 95.7% (P = .01), reported Dr. Jason C. Ye, a resident in radiation oncology at Weill Cornell Medical College, New York.

The data also suggest that breast irradiation does not increase the risk of lung cancer death, which occurred in 6 patients (1.9%) who underwent lumpectomy and radiation, and in 48 (1.6%) of those who had lumpectomies only, a difference that was not significant.

Dr. Ye noted, however, that between-group differences may begin to show up with longer follow-up.

"Although 14 years is a long time, studies have found increases in cardiac mortality and secondary cancers at 20 and 30 years after radiation. Also, there might have been a selection bias by physicians treating at the time, based on patients’ comorbidities and the patient’s health status. This might explain why the overall survival and the cardiac cause–specific survival were different between the two groups, with the no-radiation arm doing worse," he said at a media briefing.

In addition, changes in techniques introduced since the 1990s, such as three-dimensional conformal radiation, prone irradiation, hypofractionation, and intensity-modulated radiation therapy, may have effects on cardiac-specific and overall survival rates in the future, Dr. Ye said.

Dr. Ye and his colleagues reviewed SEER records on 5,385 women treated for early breast cancer during 1990-1997, and stratified them according to treatment with external-beam radiation or no radiation.

They included only patients with stage TIA N0 breast cancer identified as their first malignancy.

The authors used cause-of-death codes to identify cardiac deaths (either from cardiac disease or from atherosclerosis, breast cancer mortality, and deaths from second cancers in the chest area).

Radiation was associated with significantly lower overall mortality (relative risk, 0.69; P less than .001), breast cancer mortality (RR, 0.75; P = .02), and cardiac mortality (RR, 0.53; P less than .001).

Women with tumors in the left breast, whose hearts would presumably receive a larger dose of radiation than women with right breast tumors, were not at increased risk for cardiac-specific death. Deaths from second cancers included lung cancer in 2%; lymphomas and leukemias, each in 0.4%; soft-tissue malignancies (including the heart) in 0.06%; and cancer of the esophagus in 0.04%.

There were no significant differences between the radiation and no-radiation groups in incidence of death from second cancers.

The study was supported by the National Cancer Institute. Dr. Ye reported having no relevant disclosures.

ATLANTA – A decade after treatment for early-stage breast cancer, women who underwent surgery and radiation had higher survival rates than women who had surgery alone, with no increase in radiation-related cardiac or secondary cancer deaths, investigators reported at the annual meeting of the American Society for Radiation Oncology.

An analysis of Surveillance, Epidemiology and End Results (SEER) data on women treated for stage TIA N0 breast cancer in their mid to late 50s showed that after a median follow-up of 14 years, 10-year overall survival among the 2,397 women who received lumpectomy or mastectomy and radiation was 91.6%, compared with 87% for 2,988 women who had lumpectomy or mastectomy only (P less than .001).

Ten-year cardiac cause–specific survival was 96.7% vs. 92.7% (P less than .001), respectively. Breast cancer–specific survival was also higher among women who had undergone radiation, at 97% vs. 95.7% (P = .01), reported Dr. Jason C. Ye, a resident in radiation oncology at Weill Cornell Medical College, New York.

The data also suggest that breast irradiation does not increase the risk of lung cancer death, which occurred in 6 patients (1.9%) who underwent lumpectomy and radiation, and in 48 (1.6%) of those who had lumpectomies only, a difference that was not significant.

Dr. Ye noted, however, that between-group differences may begin to show up with longer follow-up.

"Although 14 years is a long time, studies have found increases in cardiac mortality and secondary cancers at 20 and 30 years after radiation. Also, there might have been a selection bias by physicians treating at the time, based on patients’ comorbidities and the patient’s health status. This might explain why the overall survival and the cardiac cause–specific survival were different between the two groups, with the no-radiation arm doing worse," he said at a media briefing.

In addition, changes in techniques introduced since the 1990s, such as three-dimensional conformal radiation, prone irradiation, hypofractionation, and intensity-modulated radiation therapy, may have effects on cardiac-specific and overall survival rates in the future, Dr. Ye said.

Dr. Ye and his colleagues reviewed SEER records on 5,385 women treated for early breast cancer during 1990-1997, and stratified them according to treatment with external-beam radiation or no radiation.

They included only patients with stage TIA N0 breast cancer identified as their first malignancy.

The authors used cause-of-death codes to identify cardiac deaths (either from cardiac disease or from atherosclerosis, breast cancer mortality, and deaths from second cancers in the chest area).

Radiation was associated with significantly lower overall mortality (relative risk, 0.69; P less than .001), breast cancer mortality (RR, 0.75; P = .02), and cardiac mortality (RR, 0.53; P less than .001).

Women with tumors in the left breast, whose hearts would presumably receive a larger dose of radiation than women with right breast tumors, were not at increased risk for cardiac-specific death. Deaths from second cancers included lung cancer in 2%; lymphomas and leukemias, each in 0.4%; soft-tissue malignancies (including the heart) in 0.06%; and cancer of the esophagus in 0.04%.

There were no significant differences between the radiation and no-radiation groups in incidence of death from second cancers.

The study was supported by the National Cancer Institute. Dr. Ye reported having no relevant disclosures.

ATLANTA – Severe diarrhea is a frequent complication of pelvic irradiation, but a guideline-recommended prophylactic agent, sulfasalazine, may actually make radiation-induced diarrhea worse, reported investigators at the annual meeting of the American Society for Radiation Oncology.

Updated 2007 guidelines for the prevention and treatment of mucositis recommend 500 mg oral sulfasalazine twice daily to help reduce the incidence and severity of radiation-induced enteropathy in patients treated with external beam radiotherapy to the pelvis.

But in a randomized phase III investigational study, 29% of patients who received sulfasalazine prophylactically had grade 3 or 4 diarrhea, compared with only 11% of patients who received placebo (P = .037)

The trial was halted and sulfasalazine discontinued after the data safety and monitoring board for the N08C9 trial determined that trial would not be positive even if all future toxicities in the trial occurred in the placebo arm.

"Sulfasalazine does not reduce radiotherapy-related diarrhea when used as a prophylactic agent and may increase that risk. Inclusion of sulfasalazine in clinical guidelines for radiotherapy-related enteritis prophylaxis should be reconsidered on the basis of our trial," said Dr. Robert C. Miller, professor of radiation oncology at the Mayo Clinic in Rochester, Minn.

The results highlight the need for randomized trials to confirm preliminary studies or validate clinical practices for which there is not robust evidence. Dr. Miller said.

Sulfasalazine is more widely used in Europe than in the United States, said Dr. Beth A. Erickson, professor of radiation oncology at the Medical College of Wisconsin in Milwaukee.

The standard of care in the United States for managing patients with radiation-induced diarrhea is a combination of a low-residue diet, agents that slow gastric motility and, in some cases, the use of stool-bulking agents, she said in a briefing a few days after Dr. Miller’s presentation.

The target accrual for the trial was 140 patients, but only 78 were enrolled and evaluable for the primary endpoint – maximal severity of diarrhea during and up to 6 weeks after radiotherapy according to Common Terminology Criteria for Adverse Events 4.0 – before the trial was stopped. Eligible patients were those receiving pelvic radiotherapy to a dose of more than 45 Gy, with or without chemotherapy.

Of the 40 patients in the placebo group, 8 had no diarrhea, 15 had grade 1 diarrhea, 13 had grade 2, and 4 had grade 3 diarrhea. There were no patients with grade 4 events in this group.

In the sulfasalazine group, 9 patients had no diarrhea, 11 had grade 2, 7 had grade 3 diarrhea, 10 had grade 3, and 1 had grade 4 diarrhea.

Although there were significantly more cases of grade 3 or greater diarrhea in patients treated with active drug, when all cases of diarrhea in each group were considered together, there were no significant differences between the sulfasalazine-treated patients and placebo-treated controls.

The trial was supported by the North Central Cancer Treatment Group and the Mayo Clinic. Sulfasalazine was supplied by Pfizer. Dr. Miller reported serving on the scientific advisory board of Tekcapital Ltd.

ATLANTA – Severe diarrhea is a frequent complication of pelvic irradiation, but a guideline-recommended prophylactic agent, sulfasalazine, may actually make radiation-induced diarrhea worse, reported investigators at the annual meeting of the American Society for Radiation Oncology.

Updated 2007 guidelines for the prevention and treatment of mucositis recommend 500 mg oral sulfasalazine twice daily to help reduce the incidence and severity of radiation-induced enteropathy in patients treated with external beam radiotherapy to the pelvis.

But in a randomized phase III investigational study, 29% of patients who received sulfasalazine prophylactically had grade 3 or 4 diarrhea, compared with only 11% of patients who received placebo (P = .037)

The trial was halted and sulfasalazine discontinued after the data safety and monitoring board for the N08C9 trial determined that trial would not be positive even if all future toxicities in the trial occurred in the placebo arm.

"Sulfasalazine does not reduce radiotherapy-related diarrhea when used as a prophylactic agent and may increase that risk. Inclusion of sulfasalazine in clinical guidelines for radiotherapy-related enteritis prophylaxis should be reconsidered on the basis of our trial," said Dr. Robert C. Miller, professor of radiation oncology at the Mayo Clinic in Rochester, Minn.

The results highlight the need for randomized trials to confirm preliminary studies or validate clinical practices for which there is not robust evidence. Dr. Miller said.

Sulfasalazine is more widely used in Europe than in the United States, said Dr. Beth A. Erickson, professor of radiation oncology at the Medical College of Wisconsin in Milwaukee.

The standard of care in the United States for managing patients with radiation-induced diarrhea is a combination of a low-residue diet, agents that slow gastric motility and, in some cases, the use of stool-bulking agents, she said in a briefing a few days after Dr. Miller’s presentation.

The target accrual for the trial was 140 patients, but only 78 were enrolled and evaluable for the primary endpoint – maximal severity of diarrhea during and up to 6 weeks after radiotherapy according to Common Terminology Criteria for Adverse Events 4.0 – before the trial was stopped. Eligible patients were those receiving pelvic radiotherapy to a dose of more than 45 Gy, with or without chemotherapy.

Of the 40 patients in the placebo group, 8 had no diarrhea, 15 had grade 1 diarrhea, 13 had grade 2, and 4 had grade 3 diarrhea. There were no patients with grade 4 events in this group.

In the sulfasalazine group, 9 patients had no diarrhea, 11 had grade 2, 7 had grade 3 diarrhea, 10 had grade 3, and 1 had grade 4 diarrhea.

Although there were significantly more cases of grade 3 or greater diarrhea in patients treated with active drug, when all cases of diarrhea in each group were considered together, there were no significant differences between the sulfasalazine-treated patients and placebo-treated controls.

The trial was supported by the North Central Cancer Treatment Group and the Mayo Clinic. Sulfasalazine was supplied by Pfizer. Dr. Miller reported serving on the scientific advisory board of Tekcapital Ltd.

ATLANTA – Severe diarrhea is a frequent complication of pelvic irradiation, but a guideline-recommended prophylactic agent, sulfasalazine, may actually make radiation-induced diarrhea worse, reported investigators at the annual meeting of the American Society for Radiation Oncology.

Updated 2007 guidelines for the prevention and treatment of mucositis recommend 500 mg oral sulfasalazine twice daily to help reduce the incidence and severity of radiation-induced enteropathy in patients treated with external beam radiotherapy to the pelvis.

But in a randomized phase III investigational study, 29% of patients who received sulfasalazine prophylactically had grade 3 or 4 diarrhea, compared with only 11% of patients who received placebo (P = .037)

The trial was halted and sulfasalazine discontinued after the data safety and monitoring board for the N08C9 trial determined that trial would not be positive even if all future toxicities in the trial occurred in the placebo arm.

"Sulfasalazine does not reduce radiotherapy-related diarrhea when used as a prophylactic agent and may increase that risk. Inclusion of sulfasalazine in clinical guidelines for radiotherapy-related enteritis prophylaxis should be reconsidered on the basis of our trial," said Dr. Robert C. Miller, professor of radiation oncology at the Mayo Clinic in Rochester, Minn.

The results highlight the need for randomized trials to confirm preliminary studies or validate clinical practices for which there is not robust evidence. Dr. Miller said.

Sulfasalazine is more widely used in Europe than in the United States, said Dr. Beth A. Erickson, professor of radiation oncology at the Medical College of Wisconsin in Milwaukee.

The standard of care in the United States for managing patients with radiation-induced diarrhea is a combination of a low-residue diet, agents that slow gastric motility and, in some cases, the use of stool-bulking agents, she said in a briefing a few days after Dr. Miller’s presentation.

The target accrual for the trial was 140 patients, but only 78 were enrolled and evaluable for the primary endpoint – maximal severity of diarrhea during and up to 6 weeks after radiotherapy according to Common Terminology Criteria for Adverse Events 4.0 – before the trial was stopped. Eligible patients were those receiving pelvic radiotherapy to a dose of more than 45 Gy, with or without chemotherapy.

Of the 40 patients in the placebo group, 8 had no diarrhea, 15 had grade 1 diarrhea, 13 had grade 2, and 4 had grade 3 diarrhea. There were no patients with grade 4 events in this group.

In the sulfasalazine group, 9 patients had no diarrhea, 11 had grade 2, 7 had grade 3 diarrhea, 10 had grade 3, and 1 had grade 4 diarrhea.

Although there were significantly more cases of grade 3 or greater diarrhea in patients treated with active drug, when all cases of diarrhea in each group were considered together, there were no significant differences between the sulfasalazine-treated patients and placebo-treated controls.

The trial was supported by the North Central Cancer Treatment Group and the Mayo Clinic. Sulfasalazine was supplied by Pfizer. Dr. Miller reported serving on the scientific advisory board of Tekcapital Ltd.

ATLANTA – Women with advanced cervical cancer who received cisplatin in addition to external-beam radiation and brachytherapy had slightly but significantly better disease-free survival than women who received radiation alone, according to a study by Dr. Antonio Zuliani of Campinas State University in Campinas, Brazil, and his colleagues.

In a randomized controlled trial involving 147 women with stage IIIB epidermoid cervical cancer, the hazard ratio for disease-free survival (DFS) with the addition of cisplatin was 0.52 compared with radiation alone (P = .04). There was no significant difference in overall survival (OS), however, Dr. Zuliani said at the annual meeting of the American Society for Radiation Oncology.

"The association of chemotherapy to radiotherapy was beneficial regarding disease-free survival of women with cervical cancer stage IIIB, but overall survival was not statistically significant. The toxicity of the combined treatment was not greater than that resulting from radiotherapy alone," Dr. Zuliani said.

He pointed to a meta-analysis of 18 clinical trials published in 2010, which suggested that chemoradiotherapy offered about a 10% 5-year benefit in DFS and OS for women with stage IB-IIA disease but only about a 3% advantage for women with stage IIIB disease, although the difference was not significant.

To see whether chemoradiotherapy could benefit patients with more advanced disease, the authors randomly assigned 75 women to receive 45 Gy external beam radiation therapy (EBRT) in 25 fractions to the pelvic region, with a 14.4-Gy boost to compromised parametria, and high dose-rate brachytherapy in four weekly 7-Gy fractions delivered to the crossing point of the uterine artery and ureter. An additional 72 women were assigned to receive the same radiation protocol plus weekly cisplatin at 40 mg/m² concurrent with EBRT.

After a mean follow-up of 54.9 months, 43 women in the cisplatin group (60%) were alive without disease progression, compared with 40 (53%) in the radiation-only group. The mean DFS was significantly worse for women with Karnofsky Performance Scale scores less than 90 (relative risk [RR], 2.52; P = .01), for women with bilateral wall invasion (RR, 2.93; P = .02), and for those whose baseline hemoglobin (Hb) was below 10 mg/dL (RR, 2.22; P = .04).

Mean OS also was worse among women with Karnofsky scores less than 90 (RR, 2.75) and baseline Hb below 10 mg/dL (RR, 2.82; P = .01).

There were 29 deaths (40%) in the cisplatin group and 35 (46%) in the radiation-only arm. Deaths from disease recurrence occurred in 25 (34%) women treated with cisplatin and 32 (42%) women treated with radiation only.

Acute grade 1 or 2 acute toxicities (Cooperative Group Common Toxicity Criteria of the Radiation Oncology Therapy Group) occurred in 37.5% of patients who received cisplatin, compared with 28% of those who received radiation alone; the difference was not significant. Late grade 3 or 4 toxicities were 9.7% and 3%, respectively (not significant).

Dr. Zuliani did not disclose the funding source for the study but reported having no conflicts of interest.

ATLANTA – Women with advanced cervical cancer who received cisplatin in addition to external-beam radiation and brachytherapy had slightly but significantly better disease-free survival than women who received radiation alone, according to a study by Dr. Antonio Zuliani of Campinas State University in Campinas, Brazil, and his colleagues.

In a randomized controlled trial involving 147 women with stage IIIB epidermoid cervical cancer, the hazard ratio for disease-free survival (DFS) with the addition of cisplatin was 0.52 compared with radiation alone (P = .04). There was no significant difference in overall survival (OS), however, Dr. Zuliani said at the annual meeting of the American Society for Radiation Oncology.

"The association of chemotherapy to radiotherapy was beneficial regarding disease-free survival of women with cervical cancer stage IIIB, but overall survival was not statistically significant. The toxicity of the combined treatment was not greater than that resulting from radiotherapy alone," Dr. Zuliani said.

He pointed to a meta-analysis of 18 clinical trials published in 2010, which suggested that chemoradiotherapy offered about a 10% 5-year benefit in DFS and OS for women with stage IB-IIA disease but only about a 3% advantage for women with stage IIIB disease, although the difference was not significant.

To see whether chemoradiotherapy could benefit patients with more advanced disease, the authors randomly assigned 75 women to receive 45 Gy external beam radiation therapy (EBRT) in 25 fractions to the pelvic region, with a 14.4-Gy boost to compromised parametria, and high dose-rate brachytherapy in four weekly 7-Gy fractions delivered to the crossing point of the uterine artery and ureter. An additional 72 women were assigned to receive the same radiation protocol plus weekly cisplatin at 40 mg/m² concurrent with EBRT.

After a mean follow-up of 54.9 months, 43 women in the cisplatin group (60%) were alive without disease progression, compared with 40 (53%) in the radiation-only group. The mean DFS was significantly worse for women with Karnofsky Performance Scale scores less than 90 (relative risk [RR], 2.52; P = .01), for women with bilateral wall invasion (RR, 2.93; P = .02), and for those whose baseline hemoglobin (Hb) was below 10 mg/dL (RR, 2.22; P = .04).

Mean OS also was worse among women with Karnofsky scores less than 90 (RR, 2.75) and baseline Hb below 10 mg/dL (RR, 2.82; P = .01).

There were 29 deaths (40%) in the cisplatin group and 35 (46%) in the radiation-only arm. Deaths from disease recurrence occurred in 25 (34%) women treated with cisplatin and 32 (42%) women treated with radiation only.

Acute grade 1 or 2 acute toxicities (Cooperative Group Common Toxicity Criteria of the Radiation Oncology Therapy Group) occurred in 37.5% of patients who received cisplatin, compared with 28% of those who received radiation alone; the difference was not significant. Late grade 3 or 4 toxicities were 9.7% and 3%, respectively (not significant).

Dr. Zuliani did not disclose the funding source for the study but reported having no conflicts of interest.

ATLANTA – Women with advanced cervical cancer who received cisplatin in addition to external-beam radiation and brachytherapy had slightly but significantly better disease-free survival than women who received radiation alone, according to a study by Dr. Antonio Zuliani of Campinas State University in Campinas, Brazil, and his colleagues.

In a randomized controlled trial involving 147 women with stage IIIB epidermoid cervical cancer, the hazard ratio for disease-free survival (DFS) with the addition of cisplatin was 0.52 compared with radiation alone (P = .04). There was no significant difference in overall survival (OS), however, Dr. Zuliani said at the annual meeting of the American Society for Radiation Oncology.

"The association of chemotherapy to radiotherapy was beneficial regarding disease-free survival of women with cervical cancer stage IIIB, but overall survival was not statistically significant. The toxicity of the combined treatment was not greater than that resulting from radiotherapy alone," Dr. Zuliani said.

He pointed to a meta-analysis of 18 clinical trials published in 2010, which suggested that chemoradiotherapy offered about a 10% 5-year benefit in DFS and OS for women with stage IB-IIA disease but only about a 3% advantage for women with stage IIIB disease, although the difference was not significant.

To see whether chemoradiotherapy could benefit patients with more advanced disease, the authors randomly assigned 75 women to receive 45 Gy external beam radiation therapy (EBRT) in 25 fractions to the pelvic region, with a 14.4-Gy boost to compromised parametria, and high dose-rate brachytherapy in four weekly 7-Gy fractions delivered to the crossing point of the uterine artery and ureter. An additional 72 women were assigned to receive the same radiation protocol plus weekly cisplatin at 40 mg/m² concurrent with EBRT.

After a mean follow-up of 54.9 months, 43 women in the cisplatin group (60%) were alive without disease progression, compared with 40 (53%) in the radiation-only group. The mean DFS was significantly worse for women with Karnofsky Performance Scale scores less than 90 (relative risk [RR], 2.52; P = .01), for women with bilateral wall invasion (RR, 2.93; P = .02), and for those whose baseline hemoglobin (Hb) was below 10 mg/dL (RR, 2.22; P = .04).

Mean OS also was worse among women with Karnofsky scores less than 90 (RR, 2.75) and baseline Hb below 10 mg/dL (RR, 2.82; P = .01).

There were 29 deaths (40%) in the cisplatin group and 35 (46%) in the radiation-only arm. Deaths from disease recurrence occurred in 25 (34%) women treated with cisplatin and 32 (42%) women treated with radiation only.

Acute grade 1 or 2 acute toxicities (Cooperative Group Common Toxicity Criteria of the Radiation Oncology Therapy Group) occurred in 37.5% of patients who received cisplatin, compared with 28% of those who received radiation alone; the difference was not significant. Late grade 3 or 4 toxicities were 9.7% and 3%, respectively (not significant).

Dr. Zuliani did not disclose the funding source for the study but reported having no conflicts of interest.

ATLANTA – Adjusting radiation therapy based on imaging results may improve control of locally advanced, unresectable non–small cell lung cancer, according to researchers.

When conformal radiation therapy was adapted midtreatment on the basis of 18-fluorodeoxyglucose positron emission tomography (FDG-PET) results, patients had significantly better overall survival, progression-free survival, locoregional tumor control, and locoregional progression-free survival (LR-PFS) than did stage-matched controls treated with standard radiation doses in a phase II trial.

"We all know local failure remains a problem for locally advanced non–small cell lung cancer [NSCLC]," said Dr. Feng-Ming Kong, a pediatric radiation oncologist at Georgia Regents University Cancer Center in Augusta, Georgia. "We also know tumors change during treatment in terms of activity and volume, the change differs from patient to patient, and changes in volume are more evident on PET scans than on CTs," she said at the annual meeting of the American Society for Radiation Oncology.

In a previous study at the University of Michigan in Ann Arbor, Dr. Kong and her colleagues found that tumor response during treatment was prognostic for clinical response after radiation therapy (J. Clin. Oncol. 2007;25:3116-23 [doi: 10.1200/JCO.2006.10.3747]).

"We therefore hypothesized that PET scans obtained during treatment may be able to guide us for individualized, adaptive radiotherapy to deliver a more intensive dose to the active residual tumor, resulting in improved local tumor control," she said.

They enrolled 42 patients (median age 63, 67% male, 45% squamous histology). The patients received conformal radiation therapy in 30 daily fractions of 2.2-2.8 Gy up to 17.2% of normal tissue complication probability. The patients received concurrent weekly carboplatin and paclitaxel, as well as three cycles of consolidation therapy with the same drugs.

After patients had received 40-50 Gy, they had a CT-based resimulation, and underwent PET and CT imaging studies. When the patients had reached a total physical dose of 63-86 Gy (63.5 to 92 Gy to tumor, 64 to 102 Gy to lung), their treatment was replanned based on the midtreatment PET results, with dose escalation to FDG-avid regions.

Controls were stage-matched patients who were treated at the same time with standard 60 to 66 Gy radiation doses.

At a median follow-up of 25 months (minimum 10 months), the 2-year rate of locoregional tumor control, the primary endpoint, was 68% (P vs. controls = .02) and the rate of LR-PFS was 43% (P = .007). Overall survival at 2 years also was significantly better among patients treated with adaptive radiation therapy, at 51%, compared with 23% for controls (P = .02).

There were 19 deaths, 7 from disease progression, and 12 without progression. There were no grade 4 treatment toxicities and no treatment-related deaths. Four patients had grade 2 pneumonitis and three had grade 3 pneumonitis. Grade 2 esophagitis was seen in 14 patients, and grade 3 in 5 patients. Nine patients had grade 3 dyspnea, three had bleeding, and one had both dyspnea and bleeding.

"The most common site of failure for this group is distant after this kind of treatment, and the major causes of death actually seem to be non–cancer related," Dr. Kong said.

A randomized trial, RTOG 1106, is currently testing midtreatment adaptive radiation therapy.

The study was supported by grants from the National Institutes of Health and by an ASCO Young Investigator Award. Dr. Kong disclosed serving as principal investigator on a project funded by Varian Medical Systems.

ATLANTA – Adjusting radiation therapy based on imaging results may improve control of locally advanced, unresectable non–small cell lung cancer, according to researchers.

When conformal radiation therapy was adapted midtreatment on the basis of 18-fluorodeoxyglucose positron emission tomography (FDG-PET) results, patients had significantly better overall survival, progression-free survival, locoregional tumor control, and locoregional progression-free survival (LR-PFS) than did stage-matched controls treated with standard radiation doses in a phase II trial.

"We all know local failure remains a problem for locally advanced non–small cell lung cancer [NSCLC]," said Dr. Feng-Ming Kong, a pediatric radiation oncologist at Georgia Regents University Cancer Center in Augusta, Georgia. "We also know tumors change during treatment in terms of activity and volume, the change differs from patient to patient, and changes in volume are more evident on PET scans than on CTs," she said at the annual meeting of the American Society for Radiation Oncology.

In a previous study at the University of Michigan in Ann Arbor, Dr. Kong and her colleagues found that tumor response during treatment was prognostic for clinical response after radiation therapy (J. Clin. Oncol. 2007;25:3116-23 [doi: 10.1200/JCO.2006.10.3747]).

"We therefore hypothesized that PET scans obtained during treatment may be able to guide us for individualized, adaptive radiotherapy to deliver a more intensive dose to the active residual tumor, resulting in improved local tumor control," she said.

They enrolled 42 patients (median age 63, 67% male, 45% squamous histology). The patients received conformal radiation therapy in 30 daily fractions of 2.2-2.8 Gy up to 17.2% of normal tissue complication probability. The patients received concurrent weekly carboplatin and paclitaxel, as well as three cycles of consolidation therapy with the same drugs.

After patients had received 40-50 Gy, they had a CT-based resimulation, and underwent PET and CT imaging studies. When the patients had reached a total physical dose of 63-86 Gy (63.5 to 92 Gy to tumor, 64 to 102 Gy to lung), their treatment was replanned based on the midtreatment PET results, with dose escalation to FDG-avid regions.

Controls were stage-matched patients who were treated at the same time with standard 60 to 66 Gy radiation doses.

At a median follow-up of 25 months (minimum 10 months), the 2-year rate of locoregional tumor control, the primary endpoint, was 68% (P vs. controls = .02) and the rate of LR-PFS was 43% (P = .007). Overall survival at 2 years also was significantly better among patients treated with adaptive radiation therapy, at 51%, compared with 23% for controls (P = .02).

There were 19 deaths, 7 from disease progression, and 12 without progression. There were no grade 4 treatment toxicities and no treatment-related deaths. Four patients had grade 2 pneumonitis and three had grade 3 pneumonitis. Grade 2 esophagitis was seen in 14 patients, and grade 3 in 5 patients. Nine patients had grade 3 dyspnea, three had bleeding, and one had both dyspnea and bleeding.

"The most common site of failure for this group is distant after this kind of treatment, and the major causes of death actually seem to be non–cancer related," Dr. Kong said.

A randomized trial, RTOG 1106, is currently testing midtreatment adaptive radiation therapy.

The study was supported by grants from the National Institutes of Health and by an ASCO Young Investigator Award. Dr. Kong disclosed serving as principal investigator on a project funded by Varian Medical Systems.

ATLANTA – Adjusting radiation therapy based on imaging results may improve control of locally advanced, unresectable non–small cell lung cancer, according to researchers.

When conformal radiation therapy was adapted midtreatment on the basis of 18-fluorodeoxyglucose positron emission tomography (FDG-PET) results, patients had significantly better overall survival, progression-free survival, locoregional tumor control, and locoregional progression-free survival (LR-PFS) than did stage-matched controls treated with standard radiation doses in a phase II trial.

"We all know local failure remains a problem for locally advanced non–small cell lung cancer [NSCLC]," said Dr. Feng-Ming Kong, a pediatric radiation oncologist at Georgia Regents University Cancer Center in Augusta, Georgia. "We also know tumors change during treatment in terms of activity and volume, the change differs from patient to patient, and changes in volume are more evident on PET scans than on CTs," she said at the annual meeting of the American Society for Radiation Oncology.

In a previous study at the University of Michigan in Ann Arbor, Dr. Kong and her colleagues found that tumor response during treatment was prognostic for clinical response after radiation therapy (J. Clin. Oncol. 2007;25:3116-23 [doi: 10.1200/JCO.2006.10.3747]).

"We therefore hypothesized that PET scans obtained during treatment may be able to guide us for individualized, adaptive radiotherapy to deliver a more intensive dose to the active residual tumor, resulting in improved local tumor control," she said.

They enrolled 42 patients (median age 63, 67% male, 45% squamous histology). The patients received conformal radiation therapy in 30 daily fractions of 2.2-2.8 Gy up to 17.2% of normal tissue complication probability. The patients received concurrent weekly carboplatin and paclitaxel, as well as three cycles of consolidation therapy with the same drugs.

After patients had received 40-50 Gy, they had a CT-based resimulation, and underwent PET and CT imaging studies. When the patients had reached a total physical dose of 63-86 Gy (63.5 to 92 Gy to tumor, 64 to 102 Gy to lung), their treatment was replanned based on the midtreatment PET results, with dose escalation to FDG-avid regions.

Controls were stage-matched patients who were treated at the same time with standard 60 to 66 Gy radiation doses.

At a median follow-up of 25 months (minimum 10 months), the 2-year rate of locoregional tumor control, the primary endpoint, was 68% (P vs. controls = .02) and the rate of LR-PFS was 43% (P = .007). Overall survival at 2 years also was significantly better among patients treated with adaptive radiation therapy, at 51%, compared with 23% for controls (P = .02).

There were 19 deaths, 7 from disease progression, and 12 without progression. There were no grade 4 treatment toxicities and no treatment-related deaths. Four patients had grade 2 pneumonitis and three had grade 3 pneumonitis. Grade 2 esophagitis was seen in 14 patients, and grade 3 in 5 patients. Nine patients had grade 3 dyspnea, three had bleeding, and one had both dyspnea and bleeding.

"The most common site of failure for this group is distant after this kind of treatment, and the major causes of death actually seem to be non–cancer related," Dr. Kong said.

A randomized trial, RTOG 1106, is currently testing midtreatment adaptive radiation therapy.

The study was supported by grants from the National Institutes of Health and by an ASCO Young Investigator Award. Dr. Kong disclosed serving as principal investigator on a project funded by Varian Medical Systems.

ATLANTA – For older patients with marginally operable stage 1 non–small cell lung cancer, stereotactic body radiation therapy is significantly more cost effective than surgery.

For patients with clearly operable non–small cell lung cancer (NSCLS) tumors, however, lobectomy is the most cost-effective option, reported Dr. Anand Shah, a radiation oncology resident at Columbia University Medical Center in New York.

Neil Osterweil/IMNG Medical Media

The findings, based on cost-effectiveness modeling, were robust over a wide range of assumptions, including various scenarios about treatment efficacies, toxicities, costs, and health state utilities.

"The rationale behind our study was that the traditional treatment for clearly operable patients with stage 1 lung cancer is lobectomy, whereas wedge resection and SBRT [stereotactic body radiation therapy] serve as alternatives in marginally operable patients. Given an aging population and an increased prevalence of screening, it is likely more people will be diagnosed with stage I lung cancer, and thus we felt it was critical to compare the cost effectiveness of these treatments," he said at the annual meeting of the American Society for Radiation Oncology.

The researchers created a Markov model in which hypothetical patient cohorts transition from one discrete, mutually-exclusive health state to another at fixed time increments and at defined probabilities.

For a cohort with marginally operable disease, they compared SBRT with wedge resection, and for a cohort with clearly operable disease, they compared SBRT with lobectomy. Patients in the model were older than age 65

The model assumes that in both cohorts, SBRT will be similarly efficacious, but with higher toxicity for marginally operable patients, who are more likely to experience treatment-related morbidities. The authors considered both open and less-invasive visually-assisted surgical procedures for patients undergoing lobectomy and wedge resection.

They considered costs from a Medicare perspective using 2012 dollars.

For the base case, SBRT for the marginally operable cohort cost a mean of $42,084, and the mean quality-adjusted life year (QALY) gain was 8.03 years. In contrast, wedge resection cost a mean of $51,487, for a QALY gain of 7.93 years. In statistical parlance, SBRT for this cohort was the less costly and most effective strategy.

For clearly operable patients, however, SBRT was less costly than surgery. The mean cost was $40,107 vs. $49,083, but with less efficacy at 8.21 QALY compared with 8.89 for lobectomy. The investigators calculated an incremental cost-effectiveness ratio favoring lobectomy in this cohort, at a cost of $13,200 per QALY gained.

"We conducted a number of sensitivity analyses in which we varied the cost, efficacy, utility, and toxicity data, and in the marginally operable cohort SBRT was nearly always the dominant and thus cost-effective strategy. For patients who were considered clearly operable, lobectomy was the cost-effective treatment in nearly every sensitivity analysis," Dr. Shah said.

Dr. James B. Yu, the invited discussant, said that given current data, the findings of the study generally support current practice.

"However, even if you don’t agree that lobectomy is more cost effective for the clearly operable patient, at the very least this study will illuminate what we disagree about and where better data and clearer goals are needed," he said.

Dr. Yu is a therapeutic radiologist and cancer outcomes researcher at Yale School of Medicine in New Haven, Conn.

The funding source for the study was not disclosed. Dr. Shah and Dr. Yu reported having no relevant financial disclosures.

ATLANTA – For older patients with marginally operable stage 1 non–small cell lung cancer, stereotactic body radiation therapy is significantly more cost effective than surgery.

For patients with clearly operable non–small cell lung cancer (NSCLS) tumors, however, lobectomy is the most cost-effective option, reported Dr. Anand Shah, a radiation oncology resident at Columbia University Medical Center in New York.

Neil Osterweil/IMNG Medical Media

The findings, based on cost-effectiveness modeling, were robust over a wide range of assumptions, including various scenarios about treatment efficacies, toxicities, costs, and health state utilities.

"The rationale behind our study was that the traditional treatment for clearly operable patients with stage 1 lung cancer is lobectomy, whereas wedge resection and SBRT [stereotactic body radiation therapy] serve as alternatives in marginally operable patients. Given an aging population and an increased prevalence of screening, it is likely more people will be diagnosed with stage I lung cancer, and thus we felt it was critical to compare the cost effectiveness of these treatments," he said at the annual meeting of the American Society for Radiation Oncology.

The researchers created a Markov model in which hypothetical patient cohorts transition from one discrete, mutually-exclusive health state to another at fixed time increments and at defined probabilities.

For a cohort with marginally operable disease, they compared SBRT with wedge resection, and for a cohort with clearly operable disease, they compared SBRT with lobectomy. Patients in the model were older than age 65

The model assumes that in both cohorts, SBRT will be similarly efficacious, but with higher toxicity for marginally operable patients, who are more likely to experience treatment-related morbidities. The authors considered both open and less-invasive visually-assisted surgical procedures for patients undergoing lobectomy and wedge resection.

They considered costs from a Medicare perspective using 2012 dollars.

For the base case, SBRT for the marginally operable cohort cost a mean of $42,084, and the mean quality-adjusted life year (QALY) gain was 8.03 years. In contrast, wedge resection cost a mean of $51,487, for a QALY gain of 7.93 years. In statistical parlance, SBRT for this cohort was the less costly and most effective strategy.

For clearly operable patients, however, SBRT was less costly than surgery. The mean cost was $40,107 vs. $49,083, but with less efficacy at 8.21 QALY compared with 8.89 for lobectomy. The investigators calculated an incremental cost-effectiveness ratio favoring lobectomy in this cohort, at a cost of $13,200 per QALY gained.

"We conducted a number of sensitivity analyses in which we varied the cost, efficacy, utility, and toxicity data, and in the marginally operable cohort SBRT was nearly always the dominant and thus cost-effective strategy. For patients who were considered clearly operable, lobectomy was the cost-effective treatment in nearly every sensitivity analysis," Dr. Shah said.

Dr. James B. Yu, the invited discussant, said that given current data, the findings of the study generally support current practice.

"However, even if you don’t agree that lobectomy is more cost effective for the clearly operable patient, at the very least this study will illuminate what we disagree about and where better data and clearer goals are needed," he said.

Dr. Yu is a therapeutic radiologist and cancer outcomes researcher at Yale School of Medicine in New Haven, Conn.

The funding source for the study was not disclosed. Dr. Shah and Dr. Yu reported having no relevant financial disclosures.

ATLANTA – For older patients with marginally operable stage 1 non–small cell lung cancer, stereotactic body radiation therapy is significantly more cost effective than surgery.

For patients with clearly operable non–small cell lung cancer (NSCLS) tumors, however, lobectomy is the most cost-effective option, reported Dr. Anand Shah, a radiation oncology resident at Columbia University Medical Center in New York.

Neil Osterweil/IMNG Medical Media

The findings, based on cost-effectiveness modeling, were robust over a wide range of assumptions, including various scenarios about treatment efficacies, toxicities, costs, and health state utilities.

"The rationale behind our study was that the traditional treatment for clearly operable patients with stage 1 lung cancer is lobectomy, whereas wedge resection and SBRT [stereotactic body radiation therapy] serve as alternatives in marginally operable patients. Given an aging population and an increased prevalence of screening, it is likely more people will be diagnosed with stage I lung cancer, and thus we felt it was critical to compare the cost effectiveness of these treatments," he said at the annual meeting of the American Society for Radiation Oncology.

The researchers created a Markov model in which hypothetical patient cohorts transition from one discrete, mutually-exclusive health state to another at fixed time increments and at defined probabilities.

For a cohort with marginally operable disease, they compared SBRT with wedge resection, and for a cohort with clearly operable disease, they compared SBRT with lobectomy. Patients in the model were older than age 65

The model assumes that in both cohorts, SBRT will be similarly efficacious, but with higher toxicity for marginally operable patients, who are more likely to experience treatment-related morbidities. The authors considered both open and less-invasive visually-assisted surgical procedures for patients undergoing lobectomy and wedge resection.

They considered costs from a Medicare perspective using 2012 dollars.

For the base case, SBRT for the marginally operable cohort cost a mean of $42,084, and the mean quality-adjusted life year (QALY) gain was 8.03 years. In contrast, wedge resection cost a mean of $51,487, for a QALY gain of 7.93 years. In statistical parlance, SBRT for this cohort was the less costly and most effective strategy.

For clearly operable patients, however, SBRT was less costly than surgery. The mean cost was $40,107 vs. $49,083, but with less efficacy at 8.21 QALY compared with 8.89 for lobectomy. The investigators calculated an incremental cost-effectiveness ratio favoring lobectomy in this cohort, at a cost of $13,200 per QALY gained.

"We conducted a number of sensitivity analyses in which we varied the cost, efficacy, utility, and toxicity data, and in the marginally operable cohort SBRT was nearly always the dominant and thus cost-effective strategy. For patients who were considered clearly operable, lobectomy was the cost-effective treatment in nearly every sensitivity analysis," Dr. Shah said.

Dr. James B. Yu, the invited discussant, said that given current data, the findings of the study generally support current practice.

"However, even if you don’t agree that lobectomy is more cost effective for the clearly operable patient, at the very least this study will illuminate what we disagree about and where better data and clearer goals are needed," he said.

Dr. Yu is a therapeutic radiologist and cancer outcomes researcher at Yale School of Medicine in New Haven, Conn.

The funding source for the study was not disclosed. Dr. Shah and Dr. Yu reported having no relevant financial disclosures.

ATLANTA – Men with intermediate-risk prostate cancer fared just as well over the long term with 8 weeks as with 28 weeks of neoadjuvant androgen suppression before receiving concomitant androgen suppression and radiation, said Dr. Thomas M. Pisansky at the annual meeting of the American Society for Radiation Oncology.

Based on follow-up data from the RTOG 9910 trial, 10-year disease-specific survival rates were virtually identical for the two groups at 95% and 96%. Further, 10-year biochemical failure rates were exactly the same at 27%. Nor were there any significant differences in either locoregional progression at 10 years (6% vs. 4%) or in distant metastases (6% in each group).

Neil Osterweil/IMNG Medical Media

"In 10-years of follow-up, the disease-specific survival of men treated in either fashion is extraordinarily high," said Dr. Pisansky, principal investigator for the trial, and a professor of radiation oncology at the Mayo Clinic in Rochester, Minn.

"It’s quite clear to us: The recommendation is that the preradiotherapy neoadjuvant androgen suppression need last no longer than 8 weeks. When you combine the preradiotherapy with the concurrent radiotherapy/androgen suppression, it need last no more than 16 weeks," he said at a media briefing before his presentation of the data in plenary session.

A radiation oncologist who was not involved in the study commented that it reinforces the importance of optimizing therapeutic regimens.

"From personal experience, when you shorten treatment, patients at least perceive that their quality of life is better," said Dr. Bruce G. Haffty, a radiation oncologist at the Cancer Institute of New Jersey in New Brunswick, and ASTRO president-elect.

Dr. Haffty moderated the briefing at which Dr. Pisansky discussed his data.

The investigators enrolled men with intermediate-risk prostate cancer into the trial, with accrual ranging from February 2000 through May 2004. The participants were randomly assigned to receive either 8 weeks (752 men) or 28 weeks (737 men) of neoadjuvant total androgen suppression with a luteinizing hormone-releasing-hormone analog and nonsteroidal antiandrogen. All patients then received radiation therapy of 70.2 Gy divided into 39 fractions with doses to the seminal vesicles and pelvic nodes as needed, concurrent with 8 additional weeks of total androgen suppression.

After a median follow-up of 8.7 years for all patients and 9.3 years for all survivors, 3% of all patients had died from prostate cancer. There were 30 prostate cancer deaths in the 8-week arm, and 24 in the 28-week arm, a difference that was not significant. Biochemical failures, defined as at least a 2 ng/dL rise in prostate specific antigen [PSA] from the PSA nadir), occurred in 192 of 752 patients assigned to 8 weeks neoadjuvant suppression, and in 185 of 737 assigned to 28 weeks.

Late radiation toxicities of grade 2 or greater occurred in 10% of patients in the 8-week arm, and in 8% of those in the 28-week arm. Sexual adverse events of grade 2 or greater occurred in 8% and 17%, respectively.

The evidence indicates that "there is little room for improvement in disease-specific survival and overall survival," and that studies seeking to show further benefit would be difficult to accomplish, Dr. Pisansky said.

He noted that as with breast cancer, there is likely to be a shift away from survival outcomes toward decreasing biochemical failure rates, reducing need for secondary therapies, and toward establishing an ideal radiation therapy dose.

The study was supported by grants from the National Cancer Institute. Dr. Pisansky and Dr. Haffty reported having no relevant conflicts of interest.

ATLANTA – Men with intermediate-risk prostate cancer fared just as well over the long term with 8 weeks as with 28 weeks of neoadjuvant androgen suppression before receiving concomitant androgen suppression and radiation, said Dr. Thomas M. Pisansky at the annual meeting of the American Society for Radiation Oncology.

Based on follow-up data from the RTOG 9910 trial, 10-year disease-specific survival rates were virtually identical for the two groups at 95% and 96%. Further, 10-year biochemical failure rates were exactly the same at 27%. Nor were there any significant differences in either locoregional progression at 10 years (6% vs. 4%) or in distant metastases (6% in each group).

Neil Osterweil/IMNG Medical Media

"In 10-years of follow-up, the disease-specific survival of men treated in either fashion is extraordinarily high," said Dr. Pisansky, principal investigator for the trial, and a professor of radiation oncology at the Mayo Clinic in Rochester, Minn.

"It’s quite clear to us: The recommendation is that the preradiotherapy neoadjuvant androgen suppression need last no longer than 8 weeks. When you combine the preradiotherapy with the concurrent radiotherapy/androgen suppression, it need last no more than 16 weeks," he said at a media briefing before his presentation of the data in plenary session.

A radiation oncologist who was not involved in the study commented that it reinforces the importance of optimizing therapeutic regimens.

"From personal experience, when you shorten treatment, patients at least perceive that their quality of life is better," said Dr. Bruce G. Haffty, a radiation oncologist at the Cancer Institute of New Jersey in New Brunswick, and ASTRO president-elect.

Dr. Haffty moderated the briefing at which Dr. Pisansky discussed his data.

The investigators enrolled men with intermediate-risk prostate cancer into the trial, with accrual ranging from February 2000 through May 2004. The participants were randomly assigned to receive either 8 weeks (752 men) or 28 weeks (737 men) of neoadjuvant total androgen suppression with a luteinizing hormone-releasing-hormone analog and nonsteroidal antiandrogen. All patients then received radiation therapy of 70.2 Gy divided into 39 fractions with doses to the seminal vesicles and pelvic nodes as needed, concurrent with 8 additional weeks of total androgen suppression.

After a median follow-up of 8.7 years for all patients and 9.3 years for all survivors, 3% of all patients had died from prostate cancer. There were 30 prostate cancer deaths in the 8-week arm, and 24 in the 28-week arm, a difference that was not significant. Biochemical failures, defined as at least a 2 ng/dL rise in prostate specific antigen [PSA] from the PSA nadir), occurred in 192 of 752 patients assigned to 8 weeks neoadjuvant suppression, and in 185 of 737 assigned to 28 weeks.

Late radiation toxicities of grade 2 or greater occurred in 10% of patients in the 8-week arm, and in 8% of those in the 28-week arm. Sexual adverse events of grade 2 or greater occurred in 8% and 17%, respectively.

The evidence indicates that "there is little room for improvement in disease-specific survival and overall survival," and that studies seeking to show further benefit would be difficult to accomplish, Dr. Pisansky said.

He noted that as with breast cancer, there is likely to be a shift away from survival outcomes toward decreasing biochemical failure rates, reducing need for secondary therapies, and toward establishing an ideal radiation therapy dose.

The study was supported by grants from the National Cancer Institute. Dr. Pisansky and Dr. Haffty reported having no relevant conflicts of interest.

ATLANTA – Men with intermediate-risk prostate cancer fared just as well over the long term with 8 weeks as with 28 weeks of neoadjuvant androgen suppression before receiving concomitant androgen suppression and radiation, said Dr. Thomas M. Pisansky at the annual meeting of the American Society for Radiation Oncology.

Based on follow-up data from the RTOG 9910 trial, 10-year disease-specific survival rates were virtually identical for the two groups at 95% and 96%. Further, 10-year biochemical failure rates were exactly the same at 27%. Nor were there any significant differences in either locoregional progression at 10 years (6% vs. 4%) or in distant metastases (6% in each group).

Neil Osterweil/IMNG Medical Media

"In 10-years of follow-up, the disease-specific survival of men treated in either fashion is extraordinarily high," said Dr. Pisansky, principal investigator for the trial, and a professor of radiation oncology at the Mayo Clinic in Rochester, Minn.

"It’s quite clear to us: The recommendation is that the preradiotherapy neoadjuvant androgen suppression need last no longer than 8 weeks. When you combine the preradiotherapy with the concurrent radiotherapy/androgen suppression, it need last no more than 16 weeks," he said at a media briefing before his presentation of the data in plenary session.

A radiation oncologist who was not involved in the study commented that it reinforces the importance of optimizing therapeutic regimens.

"From personal experience, when you shorten treatment, patients at least perceive that their quality of life is better," said Dr. Bruce G. Haffty, a radiation oncologist at the Cancer Institute of New Jersey in New Brunswick, and ASTRO president-elect.

Dr. Haffty moderated the briefing at which Dr. Pisansky discussed his data.

The investigators enrolled men with intermediate-risk prostate cancer into the trial, with accrual ranging from February 2000 through May 2004. The participants were randomly assigned to receive either 8 weeks (752 men) or 28 weeks (737 men) of neoadjuvant total androgen suppression with a luteinizing hormone-releasing-hormone analog and nonsteroidal antiandrogen. All patients then received radiation therapy of 70.2 Gy divided into 39 fractions with doses to the seminal vesicles and pelvic nodes as needed, concurrent with 8 additional weeks of total androgen suppression.

After a median follow-up of 8.7 years for all patients and 9.3 years for all survivors, 3% of all patients had died from prostate cancer. There were 30 prostate cancer deaths in the 8-week arm, and 24 in the 28-week arm, a difference that was not significant. Biochemical failures, defined as at least a 2 ng/dL rise in prostate specific antigen [PSA] from the PSA nadir), occurred in 192 of 752 patients assigned to 8 weeks neoadjuvant suppression, and in 185 of 737 assigned to 28 weeks.

Late radiation toxicities of grade 2 or greater occurred in 10% of patients in the 8-week arm, and in 8% of those in the 28-week arm. Sexual adverse events of grade 2 or greater occurred in 8% and 17%, respectively.

The evidence indicates that "there is little room for improvement in disease-specific survival and overall survival," and that studies seeking to show further benefit would be difficult to accomplish, Dr. Pisansky said.

He noted that as with breast cancer, there is likely to be a shift away from survival outcomes toward decreasing biochemical failure rates, reducing need for secondary therapies, and toward establishing an ideal radiation therapy dose.

The study was supported by grants from the National Cancer Institute. Dr. Pisansky and Dr. Haffty reported having no relevant conflicts of interest.