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Testicular cancer patients in a multicenter phase III trial reported worse quality of life with adjuvant radiotherapy than with chemotherapy after orchiectomy. Clinical results have yet to be calculated.
The trial randomized men to radiation or carboplatin-based chemotherapy after orchiectomy for stage I seminoma. Self-reported quality of life (QOL) was poor for both groups at baseline, but favored chemotherapy 1, 4, and 12 months afterward.
Dr. Patrick Schöffski said the German Interdisciplinary Working Party on Testicular Cancer randomized 807 patients to radiotherapy (5 x 2 Gy/week for a total dose of 26 to 30 Gy ) or two cycles of carboplatin (300-460 mg/m² for 1 hour intravenously on day 1 and day 29).
All received a European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire at four time points. About 70% complied, answering questions on physical, role, emotional, cognitive, and social functioning; and fatigue, nausea and vomiting, pain, sleep disturbances, and other QOL dimensions. The investigators compared QOL over time within the two treatment arms (Wilcoxon test) and between treatments (Mann-Whitney) in an intent-to-treat analysis.
"Not surprisingly, the quality of life of these young men at baseline was poor. These are young, otherwise healthy males with a recent diagnosis of testicular cancer, so they are still very worried about the future, and their recent surgery has major implications for sexual well-being," Dr. Schöffski, Catholic University of Leuven (Belgium), said.
After 1 month of adjuvant treatment, QOL was worse in 14 dimensions in the radiotherapy group and 7 dimensions in the chemotherapy group, he said: "Even 12 months after being randomized for the trial, which was about 10 months after stopping chemotherapy and radiotherapy, in eight dimensions of QOL the radiotherapy group was doing worse than the chemotherapy group."
Dr. Schöffski conceded that time and technology could have influenced the outcome: "These results are based largely on the relatively high-dose, larger-field radiotherapy that we gave 8 or 10 years ago. However, we also have to take into account that chemotherapy also is given in a different fashion than it was a few years ago because we dose carboplatin today according to the Calvert formula to AUC, and in this trial it was done according to creatinine clearance."
Despite these changes, Dr. Schöffski says patient feedback is a clear argument in favor of adjuvant chemotherapy. "This disease is highly curable, and you really don't want to see these guys live for 40, 50, or 60 years with persistent quality of life impairment due to the mode of treatment," he said. A third option, he added, is surveillance following orchiectomy. "That's what I prefer to do," he said.
Schöffski P. et al. Health-related quality of life (QOL) in patients with seminoma stage I treated with either adjuvant radiotherapy (RT) or two cycles of carboplatinum chemotherapy (CT): Results of a randomized phase III trial of the German Interdisciplinary Working Party on Testicular Cancer. Abstract 5050.
Commentary |
As a urologist who helped care for many men with testis cancer, particularly men with clinical stage I seminoma, when I served in the U.S. Army for 22 years, this presentation surprised me very much. In my experience, men seem to tolerate low-dose radiotherapy to the retroperitoneum very well. The 22 to 25-Gy dose prescribed to the ipsilateral primary echelon retroperitoneal node chain appeared to be very well received, and I do not recall any major (or minor) significant complications associated with this treatment. The paper by Schöffski et al. suggests otherwise in the patients studied. The investigators found that men's health-related quality of life was worse with radiation than with primary chemotherapy. As the authors point out, the radiation findings may be due to the higher doses delivered (26-30 Gy). The authors suggest that chemotherapy was delivered in a more intense way than would be done today, and that these factors taken together make the results applicable to today's treatments. Whether this is really true is debatable. A main question not addressed by this study is the long-term morbidity of primary radiotherapy vs. chemotherapy in this setting. Considering the high curability of the disease with both treatment options, a key finding would be a difference in late secondary malignancy. In the United States, primary radiotherapy remains the most common treatment recommended for young men with stage I seminoma. Most urologists and radiation oncologists agree on this point. Whether the Schöffski study turns many minds in this country toward primary chemotherapy is unknown. In my opinion, until we know about late toxicity and secondary malignancy, the standard in the U.S. should remain low-dose retroperitoneal radiotherapy. Nevertheless, I applaud the authors for their work. — Judd W. Moul, M.D.
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