Paclitaxel, bleomycin, etoposid, and cisplatin (T-BEP) as initial treatment in poor prognostic germ cell tumors (GCT). A phase II study

PURPOSE: This phase II study was designed to determine the toxicity and activity of single-agent gemcitabine in heavily pretreated patients with germ cell tumors.PATIENTS AND METHODS: From March 1996 through November 1997, 21 patients were enrolled onto a phase II study of gemcitabine 1,200 mg/m2, given on days 1, 8, and 15 every 4 weeks. One patient was unassessable because he never received any gemcitabine. Thirteen of 20 patients had received three prior regimens, and 13 patients were platinum refractory (progression during or within 4 weeks of platinum treatment). There were five extragonadal cases and two patients with late relapse (relapse beyond 2 years).RESULTS: Gemcitabine was well tolerated. Only one patient had grade 3 or 4 nonhematologic toxicity (grade 3 nausea). Six of 20 patients had grade 3 leukopenia. There were no episodes of granulocytopenic fever, and no patient required platelet transfusion. Three (15%) of 20 patients achieved an objective response, including one complete remission. Three additional patients had a minor radiographic or serologic response.CONCLUSION: Gemcitabine had definite activity in this heavily pretreated germ cell tumor patient population.

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Phase II Study of Imatinib Mesylate in Chemotherapy Refractory Germ Cell Tumors Expressing KIT

American Journal of Clinical Oncology ◽

10.1097/01.coc.0000195086.47548.ef ◽

2006 ◽

Vol 29 (1) ◽

pp. 12-13 ◽

Cited By ~ 75

Author(s):

Lawrence H. Einhorn ◽

Mary J. Brames ◽

Michael C. Heinrich ◽

Christopher L. Corless ◽

Ali Madani

Keyword(s):

Germ Cell ◽

Imatinib Mesylate ◽

Phase Ii ◽

Phase Ii Study ◽

Germ Cell Tumors

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Phase II study of gemcitabine, carboplatin and veliparib in multiple relapsed/refractory germ cell tumors (GCTs).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e17009 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e17009-e17009

Author(s):

Michal Mego ◽

Daniela Svetlovska ◽

Maria Reckova ◽

Katarina Kalavska ◽

Jana Obertova ◽

...

Keyword(s):

Germ Cell ◽

Phase Ii ◽

Partial Remission ◽

Phase Ii Study ◽

Parp Inhibitor ◽

Germ Cell Tumors ◽

Progression Free Survival ◽

Median Number ◽

Early Event ◽

End Point

e17009 Background: GCTs represent a model for the cure of cancer. Nonetheless, a small proportion of patients develop disease recurrence. PARP is overexpressed in GCTs compared to normal testis and PARP overexpression is early event in GCTs development. Gemcitabine and carboplatin showed activity in refractory GCTs. This study aimed to determine the efficacy and toxicity of gemcitabine, carboplatin and PARP inhibitor, veliparib, in patients with multiple relapsed/refractory GCTs. Methods: Fifteen patients with multiple relapsed/refractory GCTs were enrolled in the phase II study from October 2016 to October 2020. All patients were pretreated with at least 2 cisplatin-based therapies (median 2, range 2 – 4); 3 tumors (20.0%) were absolutely refractory to cisplatin and 5 patients (33.3%) had visceral non-pulmonary metastases. Gemcitabine was administered at a dose 800mg/m2 day 1 and 8 every 3 weeks; carboplatin AUC = 4, day 1, every 3 weeks and veliparib 250mg bid day continuously. The primary end point was 12-months progression-free survival (PFS), if < 8 patients experienced 12-months PFS, the treatment will be considered ineffective. Results: Median age was 31 years (range: 22 – 48 months). Median number of treatment cycles was 4 (range 2 – 8). During a median follow-up period of 9.2 months (range: 1.9 – 23.8), all (100%) patients experienced disease progression and 14 patients (93.3%) died. Twelve-months PFS was achieved in 1 (6.7%) patient. Median PFS was 3.1 months, 95%CI (2.2 – 3.9) and median OS was 10.5 months, 95% CI (8.9 – 11.1). Partial remission was observed in 4 (26.7%) and disease stabilization in 5 (33.3%) of patients. Favorable response (complete or partial remission with negative serum tumor markers) experienced 3 (20%) patients. Treatment was well tolerated, however, 12 (80%) of patients experienced grade 3/4 neutropenia, 9 (60%) anemia, 14 (93.3%) thrombocytopenia and 2 (13.3%) febrile neutropenia. Conclusions: This study failed to achieve its primary end point and our data suggest limited efficacy of gemcitabine, carboplatin and veliparib in multiple relapsed/refractory germ cell tumors. Clinical trial information: NCT02860819.

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