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One-year high-dose interferon reaffirmed for melanoma treatment
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Adjuvant high-dose interferon induction given for 4 weeks did not improve RFS or OS in patients with resectable intermediate- and high-risk melanoma, according to updated study results from the 2011 ASCO Annual Meeting.
“These results support the importance of longer high-dose interferon treatment duration to optimize treatment outcomes,” said Sanjiv S. Agarwala, MD, section chief of hematology/oncology at St. Luke’s Hospital in Bethlehem, Pa. “The approved 1-year adjuvant [high-dose interferon] regimen of induction followed by maintenance should not be shortened to 4 weeks and should remain a standard of care for patients with high-risk disease, T4N0 or node-positive disease.” Agarwala presented the updated data at the 2011 ASCO annual meeting here.
Between December 1998 and October 2010, 1,150 patients with intermediate- and high-risk melanoma defined as T3 or any thickness with microscopically node-positive disease (N1a-N2a) were randomly assigned to receive either observation (n=569) or postoperative adjuvant interferon alpha-2b 20 mU/m2 per day for 5 days per week for 4 weeks (n=581). The median patient age was 52 years. The primary endpoint of the trial was relapse-free survival; the secondary endpoint was OS.
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In August 2010, an interim analysis was conducted with relapse-free survival data in 838 patients and OS data in 1,091 patients. Agarwala presented updated results of 975 patients as of April 8, with 77% complete information for relapse-free survival and 84% information for OS.
Patients were chosen to detect a 15% relative increase in the media time-to-event for those not cured. Agarwala said 23% of patients were stage T2N0; 46% were T3N0; 14% were T4N0; and 18% were T1-4, N1a-2a. In the treatment group, 18% were node-positive.
The median relapse-free survival for the observation arm (n=481) was 7.8 years (95% CI, 5.8-9.8) compared with 7.3 years (95% CI, 7.0-9.5) for the interferon arm (n=494; P=.69). The 5-year OS rate for the observation arm was 85% (95% CI, 81-89; n=546); for the interferon induction-only arm, the rate was 82% (95% CI, 78-86; n=565).
“Based upon this analysis, the data safety committee recommended the study be terminated in October 2010, as there was no evidence of interferon benefit and no possibility that the study would show a benefit of interferon, even if it met its full accrual,” Agarwala said. An analysis by prognostic factors (ulceration, nodal disease, stage and Breslow’s thickness) found no significant differences between the treatment group vs. observation.
“Adjuvant therapy with high-dose interferon induction phase only for 4 weeks was not sufficient to improve [relapse-free survival] or OS vs. observation in this patient population,” Agarwala said. – by Whitney McKnight and Carey Cowles
For more information:
- Agarwala S. #8505. Presented at: 2011 ASCO Annual Meeting; June 3-7; Chicago.
Disclosure: Dr. Agarwala reported being a consultant for and receiving honoraria from Schering-Plough.
The easier and straightforward answer for this result is that 1 month does not work. But one has to take into consideration the population that was randomized. It was a very low-risk population; only 20% of patients were stage III, and we’re not sure about the exact risk of the other 80%. And, also, there is the possibility that patients on relapse, as this was an open-label study, were able to receive adjuvant interferon.
– Helen Gogas, MD
Assistant professor of medical oncology, Athens University Medical School, Greece
Director of the Oncology Outpatient Clinic of the 1st Department of Internal Medicine at Laiko University Hospital of Athens, Greece
Disclosure: Dr. Gogas has served in a consultant or advisory role for and received honoraria from Schering-Plough.