Gemcitabine in patients with relapsed or cisplatin-refractory testicular cancer

Purpose: Despite generally high cure rates in patients with metastatic test icular germ cell tumors, patients with incomplete response to cisplatin-bas ed first-line therapy or with relapsed disease after high-dose salvage chem otherapy have a very poor prognosis. This phase II study evaluates the use of gemcitabine in patients with intensively pretreated or cisplatin-refract ory testicular germ cell cancers. Patients and Methods: Thirty-five patients (median age, 33 years) were enro lled; 31 patients were fully assessable. All patients had metastatic nonsem inomatous germ cell tumors; eight patients had extragonadal primary tumors. Twenty patients (63%) had lung metastases, and 12 patients (39%) had liver metastases. The median number of prior cisplatin-based chemotherapy cycles was seven; 22 patients (71%) had received high-dose chemotherapy with auto logous stem-cell transplantation, and 19 patients (61%) had received treatm ent with paclitaxel. Seventeen patients (54%) were considered refractory or absolutely refractory to chemotherapy. Results: Six of 31 assessable patients (19%) responded favorably to gemcita bine, 11 patients (35%) displayed no change, and 14 patients (45%) had dise ase progression. The median time to treatment failure was 4 months (range, 2 to 9+ months), and the median survival was 6 months (range, 2 to 23 month s). Patients received a median of six gemcitabine applications. Ten patient s (32%) required dose reductions, mainly owing to hematologic toxicity. Gra de 3/4 granulocytopenia occurred in four patients (13%)and grade 3/4 thromb ocytopenia in seven patients (22%). One case of severe sepsis was observed. Conclusion: Gemcitabine displays antitumor activity in intensively pretreat ed and refractory germ cell tumors. Responses were observed in approximatel y 20% of patients, including three of 22 patients after previous high-dose chemotherapy and one of four patients with mediastinal rumors. Gemcitabine may be a reasonable palliative option for intensively pretreated patients a nd should be further investigated to define its role in the risk-adapted tr eatment strategies for germ cell tumors. (C) 1999 by American Society of Cl inical Oncology.