David Brill
Radiotherapy combined with 5-fluorouacil (5-FU) and mitomycin-C should remain the standard of care for anal cancer, say UK investigators.
Pull quote: “We recommend that radiotherapy with 5-FU and mitomycin-C remains the standard of care for this condition.”Results of the largest-ever trial for anal cancer showed no benefit from switching mitomycin-C for cisplatin, or from adding maintenance chemotherapy to the regimen.
The Second UK Phase III Anal Cancer Trial (ACT II) included 940 patients (median age 58), followed up for a median of 3 years. Those who relapsed or failed to respond to therapy were treated with surgery.
The results of the trial provide good news, despite the lack of benefit shown by the alternative treatment regimens, said lead investigator Dr. Roger James, a consultant radiation oncologist at Maidstone Hospital, Kent, UK.
“Overall the outcome for patients in this study is excellent, with a 95 percent complete response rate at 6 months and an 85 percent survival at 3 years. These are very good results relative to the international trials published so far. We recommend that radiotherapy with 5-FU and mitomycin-C remains the standard of care for this condition,” he said.
Patients were recruited from 2001 to 2008. All were given radiotherapy and 5-FU, and were randomized to receive either additional mitomycin-C or cisplatin. They were then further randomized: half received an extra round of maintenance chemotherapy, comprising two cycles of cisplatin and 5-FU at weeks 11 and 14, and half did not.
Six-month response rates were 94.5 percent for mitomycin-C and 95.4 percent for cisplatin (P=0.53). Non-hematological toxicity was comparable between the groups, affecting 60.2 percent of mitomycin-C patients, compared to 64.6 percent of cisplatin patients (P=0.17). There was, however, more hematological toxicity in the mitomycin-C group (24.7 percent) compared to the cisplatin group (13.4 percent; P<0.001).>
Pull quote: “We recommend that radiotherapy with 5-FU and mitomycin-C remains the standard of care for this condition.”Results of the largest-ever trial for anal cancer showed no benefit from switching mitomycin-C for cisplatin, or from adding maintenance chemotherapy to the regimen.
The Second UK Phase III Anal Cancer Trial (ACT II) included 940 patients (median age 58), followed up for a median of 3 years. Those who relapsed or failed to respond to therapy were treated with surgery.
The results of the trial provide good news, despite the lack of benefit shown by the alternative treatment regimens, said lead investigator Dr. Roger James, a consultant radiation oncologist at Maidstone Hospital, Kent, UK.
“Overall the outcome for patients in this study is excellent, with a 95 percent complete response rate at 6 months and an 85 percent survival at 3 years. These are very good results relative to the international trials published so far. We recommend that radiotherapy with 5-FU and mitomycin-C remains the standard of care for this condition,” he said.
Patients were recruited from 2001 to 2008. All were given radiotherapy and 5-FU, and were randomized to receive either additional mitomycin-C or cisplatin. They were then further randomized: half received an extra round of maintenance chemotherapy, comprising two cycles of cisplatin and 5-FU at weeks 11 and 14, and half did not.
Six-month response rates were 94.5 percent for mitomycin-C and 95.4 percent for cisplatin (P=0.53). Non-hematological toxicity was comparable between the groups, affecting 60.2 percent of mitomycin-C patients, compared to 64.6 percent of cisplatin patients (P=0.17). There was, however, more hematological toxicity in the mitomycin-C group (24.7 percent) compared to the cisplatin group (13.4 percent; P<0.001).>
Maintenance chemotherapy had no impact on 3-year recurrence-free survival rates, which were 75 percent for both groups. Overall survival at 3 years was also not significantly different between those who received maintenance therapy (85 percent) and those who didn’t (84 percent).
The ACT II trial results bring another blow to hopes that cisplatin would prove beneficial in anal cancer. Early data had shown anal tumors to be sensitive to a combination of cisplatin and fluorouacil, but a trial of 682 patients, published last year, found that it offered no survival benefits over mitomycin-based therapy. Moreover, cisplatin-treated patients were almost twice as likely to undergo colostomy as those treated with mitomycin (19 percent versus 10 percent; P=0.02), the US Gastrointestinal Intergroup trial Radiation Therapy Oncology Group reported. [JAMA. 2008;299(16):1914-1921]
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