SAN FRANCISCO, CA USA (UroToday.com) - In this study, previously treated patients with progressive germ cell tumors (GCT) were eligible if they had not received or were not candidates for high-dose chemotherapy (HDCT).
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Treatment was every 2 weeks in 6-week cycles, and the primary endpoint was response rate. Patients on arm one received flavopiridol 70mg/m2 plus oxaliplatin 85mg/m2, and patients in arm 2 (flavopiridol + FOLFOX) tested identical doses of flavopiridol and oxaliplatin plus 5-FU (400mg/m2 bolus, then 1800mg/m2 over 48 hours) and leucovorin (LV) 400mg/m2.
A total of 36 patients (7 arm 1, 29 arm 2) were enrolled in the study, and of those, 33 had non-seminoma. Twenty -even patients had primary testis and 7 had primary mediastinum tumors. Twenty-two patients had received prior HDCT and 13 had LR (> 2 years), including 2 on arm 1 and 11 on arm 2. Since there was no response in arm 1 (0/7 patients), this arm was closed early. Of 25 evaluable patients on arm 1, 6 achieved a PR, 9 had SD, and 10 had PD. Five out of 10 evaluable LR patients on arm 1 had a PR, including one pathologic CR, one PR-negative markers who received radiation (RT) to a residual bone metastasis, and 1 PR-positive markers who received RT to a residual nodal mass. These 3 patients remain disease-free ≥ 19 months post-chemotherapy and ≥ 17months post-RT or surgery. Median progression-free survival and overall survival were 2.3 months and 7.3 months for all patients, respectively, and 3.2 months and 11.2 months for patients in arm 2.
The important take-home point of this phase 2 study is that, although neither arm met the hypothesized endpoint, flavopiridol plus FOLFOX was particularly active in later relapse patients, with approximately a 50% overall RR. Further studies are certainly needed to evaluate the use of FOLFOX, with or without flavopiridol, in late-relapse patients.
Highlights of a presentation by Darren Richard Feldman at the 2014 Genitourinary Cancers Symposium - January 30 - February 1, 2014 - San Francisco Marriott Marquis - San Francisco, California USA
Memorial Sloan Kettering Cancer Center, New York, NY USA