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© 2002 American Society for Clinical Oncology
Cisplatin and Dacarbazine With or Without Subcutaneous Interleukin-2 and Interferon Alfa-2b in Advanced Melanoma OutpatientsWright State University School of Medicine, Dayton, OH To the Editor:Ridolfi et al1 conclude that their study comparing cisplatin and dacarbazine with or without interleukin-2 (IL-2) and interferon alfa-2b "reinforces the already widespread opinion that advanced melanoma is best treated with combined chemoimmunotherapeutic drugs". We find this conclusion surprising in view of the fact that their results show that the addition of IL-2 and interferon alfa-2b did not improve overall survival, time to progression, or even overall response. They state that the 11-month overall survival in the combined treatment arm "does not differ greatly from the best results with high-dose IL-2–containing regimens reported in the literature." One could make the same comparison with the chemotherapy-only arm of this study. Finally, the authors make much of the issue of quality of life, and state that an additional aim of their study was to evaluate this. Their subjects underwent quality-of-life assessment before beginning treatment and before each cycle. Oddly, the results of these assessments are not reported. REFERENCES
1. Ridolfi R, Chiaron-Sileni V, Guida M, et al: Cisplatin, dacarbazine with or without subcutaneous interleukin-2 and interferon alfa-2b in advanced melanoma outpatients: Results from an Italian multicenter phase III randomized clinical trial. J Clin Oncol 20: 1600-1607, 2002
Response
Pierantoni Hospital In Reply:There has undoubtedly been a trend in recent years in the literature showing that combined chemoimmunotherapeutic drugs improve the survival of patients with advanced melanoma. The overall survival (OS) of patients with advanced melanoma passed from 6 to 9 months in Lotze et al’s1 description to more than 11 months with chemoimmunotherapeutic treatments, as is highlighted in the meta-analysis by Keilholz et al2 and Allen et al3 conducted on a very large number of patients. The study by Eton et al,4 presented at the Thirty-Sixth Annual Meeting of the American Society of Clinical Oncology in 2000, seemed to indicate, for the first time, a significant difference in terms of OS between chemotherapy (9.5 months) and biochemotherapy (11.8 months). The definitive study recently published confirmed these data, albeit with borderline statistical significance.5 However, this study required a recruitment of more than 7 years because of the complexity of the treatment scheme, which had a marked toxicity. The results of our work are in line with this tendency, reporting an OS of 9.5 months for the chemotherapy-only arm versus 11 months for the biochemotherapy arm, albeit not reaching statistical significance. Therefore, we believe that we were correct in sustaining that our results "do not differ greatly from the best results with high-dose IL-2-containing regimens reported in the literature".6 Furthermore, we would like to point out that recruitment for our study was completed in less than 3 years and that therapy was administered in an out-patient setting and was well-tolerated. This therapy is therefore feasible in a large majority of patients with advanced melanoma who are less numerous than those with other cancer pathologies in which it is easier to conduct higher powered studies. With regard to quality-of-life (QOL) assessment, the preliminary data of which were presented at the Thirty-Seventh Annual Meeting of the American Society of Clinical Oncology in 2001,7 a paper comprising definitive results was recently submitted for publication. Briefly, we prospectively studied baseline QOL using the Rotterdam Symptom Checklist before and after each cycle in 80% of the 176 randomized patients. We found that the QOL decreased in both chemotherapy and biochemotherapy patients with respect to baseline in all domains (Overall Global Life Quality, Activity Level, Physical Symptom Distress, and Psychological Distress) and was slightly worse in the biochemotherapy-treated group, with no significant differences between the two arms. REFERENCES 1. Lotze MT, Dallal RM, Kirkwood JM, et al: Cutaneous melanoma, in De Vita VT, Hellman S, Rosenberg SA (eds): Cancer, Principles and Practice of Oncology, ed 6. Philadelphia, PA, Lippincott Williams & Wilkins, 2001, pp 2012-2069
2. Keilholz U, Conradt C, Legha SS, et al: Results of interleukin-2-based treatment in advanced melanoma: A case record-base analysis of 631 patients. J Clin Oncol 16: 2921-2929, 1998 3. Allen IE, Kupelnick B, Kumashiro M: Efficacy of interleukin-2 in the treatment of metastatic melanoma-systemic review and metastasis-analysis. Cancer Therapeutics 1: 168-173, 1998 4. Eton O, Legha S, Bedikian A, et al: Phase III randomized trial of cisplatin, vinblastine and dacarbazine (CVD) plus interleukin-2 (IL-2) and interferon-alpha-2b (IFN) versus CVD in patients (Pts) with metastatic melanoma. Proc Am Soc Clin Oncol 19: 552a, 2000 (abstr 2174)
5. Eton O, Legha SS, Bedikian AY, et al: Sequential biochemotherapy versus chemotherapy for metastatic melanoma: Results from a phase III randomized trial. J Clin Oncol 20: 2045-2052, 2002
6. Ridolfi R, Chiaron-Sileni V, Guida M, et al: Cisplatin, dacarbazine with or without subcutaneous interleukin-2 and interferon alfa-2b in advanced melanoma outpatients: Results from an Italian multicenter phase III randomized clinical trial. J Clin Oncol 20: 1600-1607, 2002 7. Chiaron-Sileni V, Lo Presti G, Chiara A, et al: Quality of life (QoL) evaluation in randomized trials of chemotherapy (CT) vs biochemotherapy (BioCT) in advanced melanoma (AM). Proc Am Soc Clin Oncol 20: 352a, 2001 (abstr 1404)
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Copyright © 2002 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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