Abstract
116 patients with testicular cancer and bulky metastatic disease entered a phase-II-trial with double dose-cisplatin/etoposide/bleomycin for 3 to 4 cycles in four week intervals, followed by surgery in case of residual tumor and additional two cycles of chemotherapy if residual malignant tumor was found in the resected specimen. Of 108 evaluable patients 46% achieved a CR, 25% NED (CR + NED 72%) and 10%) a PR with markernormalization, with an overall “favourable response”-rate of 82%. The relapse rate is 12% with a median time to relapse of 9 (2–24) mos. after a median follow up of 46 mos. Presently 63 % are CR/NED and the calculated survival including early and toxic death is 69%. This seems not to be superior to standard dose cisplatinum/etoposide/bleomycin. The possible beneficial effect of double-dosecisplatinum in patients with advanced disease will be elucidated by an ongoing SECSG-trial.
Zusammenfassung
In einer Phase-II-Studie wurde die Toxizität und Antitumoraktivität von Doppeldosis-Cisplatin/Etoposid/Bleomycin bei Patienten mit weit fortgeschrittenem Hodentumor untersucht, die die Kriterien für “advanced disease” erfüllen. Von 116 in die Studie aufgenommenen Patienten sind 108 auswertbar: CR 46%, NED 26%, CR + NED 72%, PR mit Markernormalisierung 10%, entsprechend 82% “favourable response”, 12% PR ohne Markernormalisierung, 2% NC, 4% P. Die Rezidivrate beträgt 12% nach einer medianen Zeit von 9 (2–24) Monaten. Nach einem minimalen Follow up für jeden Patienten von 2 Jahren und einem medianen Follow up von 46 Monaten beträgt die CR/NED-Rate zur Zeit 63% und die errechnete Überlebensrate 69%. Die Toxizität dieses Regimes ist erheblich. Ob die höhere Toxizität durch die hohe Cisplatindosis durch eine höhere Wirksamkeit gerechtfertigt ist, ist von dieser Phase-II-Studie nicht ableitbar; diese Frage wird durch eine laufende SECSG-Studie beantwortet sein. Unabhängig hiervon ist die Therapie von Patienten mit “advanced disease” dringend verbesserungsbedürftig.
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Schmoll, HJ. et al. (1988). Doppeldosis-CisplatinlEtoposid/ Bleomycin („PHDEB“) bei Hodentumoren mit groβer Tumormasse. Ergebnis einer kooperativen AIO-Studie. In: Schmoll, HJ., Weißbach, L. (eds) Diagnostik und Therapie von Hodentumoren. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-73492-2_27
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DOI: https://doi.org/10.1007/978-3-642-73492-2_27
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