BACKGROUND: The standard treatment for patients with metastatic GCT relapsing after first-line chemotherapy is based on a cisplatin and ifosfamide-containing 3-drug regimen, which usually yields a complete response (CR) rate < 50%.
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/m2 day 1 and 5, ifosfamide 1200 mg/m2/d day 1-5, cisplatin 20 mg/m2/d, day 1-5, G-CSF 263 µg/d day 7-15, repeated every 3 weeks for 4 cycles. Eligibility criteria were that patients had favorable prognostic factors to conventional-dose salvage chemotherapy including a testis primary tumor and a previous complete response (CR) to first-line chemotherapy for metastatic disease. The primary endpoint was the CR rate and a two-stage Simon design was used.
RESULTS: 37 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 3-4 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.
Written by:
Fizazi K, Gravis G, Flechon A, Geoffrois L, Chevreau C, Laguerre B, Delva R, Eymard JC, Rolland F, Houede N, Laplanche A, Burcoveanu D, Culine S. Are you the author?
Institut Gustave Roussy, Department of Cancer Medicine, Villejuif.
Reference: Ann Oncol. 2014 Mar 4. Epub ahead of print.
doi: 10.1093/annonc/mdu099
PubMed Abstract
PMID: 24595454
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