Combining gemcitabine, cisplatin, and ifosfamide (GIP) is active in patients with relapsed metastatic germ-cell tumors (GCT): a prospective multicenter GETUG phase II trial
| Autor: | Lionnel Geoffrois, Remy Delva, N. Houede, Frederic Rolland, Agnès Laplanche, J.-C. Eymard, B. Laguerre, Aude Flechon, Karim Fizazi, Stéphane Culine, D. Burcoveanu, G. Gravis, Christine Chevreau |
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| Přispěvatelé: | Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre Léon Bérard [Lyon], Institut de Cancérologie de Lorraine - Alexis Vautrin (ICL), Institut Claudius Regaud, CRLCC Institut Claudius Regaud, CRLCC Eugène Marquis (CRLCC), Institut de cancérologie de l'Ouest - Paul Papin (ICO - Paul Papin), CRLCC Jean Godinot, CRLCC René Gauducheau, Centre Hospitalier Régional Universitaire de Nîmes (CHRU Nîmes), Institut Bergonié - CRLCC Bordeaux, Institut de recherche en cancérologie de Montpellier (IRCM - U896 Inserm - UM1), CRLCC Val d'Aurelle - Paul Lamarque-Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 1 (UM1), Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Hôpital Saint-Louis, Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Institut Bergonié [Bordeaux], Université Montpellier 1 (UM1)-CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7) |
| Rok vydání: | 2014 |
| Předmět: |
Male
Oncology 030232 urology & nephrology Salvage therapy Kaplan-Meier Estimate Deoxycytidine Gastroenterology Testicular Neoplasms/*drug therapy/mortality/pathology 0302 clinical medicine Neoplasms Antineoplastic Combined Chemotherapy Protocols Prospective Studies Ifosfamide Hematology Middle Aged Neoplasms Germ Cell and Embryonal Ifosfamide/administration & dosage Chemotherapy regimen 3. Good health Treatment Outcome Germ Cell and Embryonal/*drug therapy/mortality/secondary Lymphatic Metastasis 030220 oncology & carcinogenesis medicine.drug Adult medicine.medical_specialty [SDV.CAN]Life Sciences [q-bio]/Cancer Drug Administration Schedule Young Adult 03 medical and health sciences Testicular Neoplasms Internal medicine Deoxycytidine/administration & dosage/analogs & derivatives medicine Local/*drug therapy Humans Antineoplastic Combined Chemotherapy Protocols/*therapeutic use Progression-free survival Survival rate Salvage Therapy business.industry medicine.disease Gemcitabine Regimen Neoplasm Recurrence Cisplatin Neoplasm Recurrence Local business Cisplatin/administration & dosage Febrile neutropenia |
| Zdroj: | Annals of Oncology Annals of Oncology, Oxford University Press (OUP), 2014, 25, pp.987--91. ⟨10.1093/annonc/mdu099⟩ Annals of Oncology, Elsevier, 2014, 25, pp.987--91. ⟨10.1093/annonc/mdu099⟩ |
| ISSN: | 0923-7534 1569-8041 |
| DOI: | 10.1093/annonc/mdu099 |
| Popis: | International audience; BACKGROUND: The standard treatment of patients with metastatic germ-cell tumor (GCT) relapsing after first-line chemotherapy is based on a cisplatin and ifosfamide-containing three-drug regimen, which usually yields a complete response (CR) rate \textless50%. As gemcitabine consistently displayed activity in patients with advanced GCT and as synergy with cisplatin was reported, we integrated this drug into the salvage triplet regimen and assessed its activity in this phase II study. PATIENTS AND METHODS: The GIP regimen consisted in gemcitabine 1000 mg/m(2) day 1 and 5, ifosfamide 1200 mg/m(2)/day day 1-5, cisplatin 20 mg/m(2)/day day 1-5, and granulocyte colony-stimulating factor 263 mug/day day 7-15, repeated every 3 weeks for four cycles. Eligibility criteria were that patients had favorable prognostic factors to conventional-dose salvage chemotherapy including a testis primary tumor and a previous CR to first-line chemotherapy for metastatic disease. The primary end point was the CR rate and a two-stage Simon design was used. RESULTS: Thirty-seven patients were accrued and 29 (78%) achieved a favorable response, including a CR in 20 (54%) and a partial response with normalization of tumor markers (PRm-) in 9 (24%). With a median follow-up of 53 months (13-81), the 2-year overall survival rate is 73% (57%-84%) and the continuous progression-free survival rate is 51% (35%-66%). Myelosuppression was the main toxicity including febrile neutropenia in 8 (22%) patients and 18 (50%) cases required platelet infusion. No grade 3 and 4 peripheral neurotoxicity or renal toxicity occurred. Two patients died of treatment-related toxicity, one of them with cancer progression. CONCLUSION: In a multicenter context, four cycles of the GIP regimen achieved a high CR rate in patients with relapsed testicular GCT. The GIP regimen avoided severe neurotoxicity and yielded a high survival rate. CLINICAL TRIAL NUMBER: NCT00127049. |
| Databáze: | OpenAIRE |
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