863P - Multi-cycle high-dose chemotherapy with TI-CE regimen for patients with relapsed/refractory germ cell tumors - a single institution experience

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Germ Cell Tumours
Presenter Ugo De Giorgi
Authors U. De Giorgi1, G. Rosti2, B. Kopf1, C. Ferrario1, G. Papiani3, R. De Vivo4, A.L. Gentile5, F. Fabbri1, M. Bragagni1, D. Amadori1
  • 1Medical Oncology, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), 47014 - Meldola/IT
  • 2Medical Oncology, Ospedale civile, Treviso/IT
  • 3Medical Oncology, Ospedale Santa Maria delle Croci, Ravenna/IT
  • 4Medical Oncology, Ospedale San Bortolo, Vicenza/IT
  • 5U.o.c. Oncologia - Asl Teramo, Ospedale Mazzini, IT-64100 - Teramo/IT

Abstract

Background

A large international phase III randomized trial (TIGER study) has been recently planned to compare the TI-CE multi-cycle high-dose chemotherapy (HDCT) with standard chemotherapy as salvage treatment for patients with relapsed germ cell tumors (GCT), but to date there are no reported experiences with this regimen other than the phase 2 study from MSKCC (Feldman et al – JCO 2010). We present preliminary results of our experience with TI-CE in relapsed/refractory GCT patients.

Methods

From August 2009 to April 2012, patients with relapsed/refractory GCT received TI-CE comprising a mobilizing phase with paclitaxel and ifosfamide (TI) with leukapheresis of peripheral blood progenitor cells (PBPCs), followed by 3 HDCT courses with CE (carboplatin AUC 21 and etoposide 1200 mg/m2), with PBPC reinfusion. Biosimilar filgrastim (Zarzio®) was used in the HDCT phase for all patients after PBPC reinfusion.

Results

26 patients (25 males, median age 34) started on TI, but 3 of them did not receive CE: two had rapidly progressive symptomatic brain metastases, the third one refused HDCT. Of 23 patients, 20 completed the TI-CE regimen and are evaluable, while 3 are still receiving treatment. There were no treatment-related deaths. The median number of days from the start of CE until recovery of neutrophils to 1,000/mm3 was 14. Twelve (60%) of the 20 evaluable patients achieved a complete remission (CR) (5 clinical CR, 5 pathological CR, 2 surgical CR), 5 had marker-negative partial remissions lasting 2, 2 + , 2 + , 6+ and 21+ months, and 3 progressed. After a median follow-up of 13 months (range, 2 to 33+), 15 (75%) evaluable patients are continuously progression-free. Of 4 mediastinal primary nonseminomatous GCT, 2 achieved a CR (1 sCR and 1 pCR) lasting 7 and 12+ months, respectively.

Conclusions

Our experience confirms that the TI-CE regimen is safe and active, with a response rate and a recovery time of neutrophils after CE similar to that reported in the MSKCC study. Updated results will be presented at the meeting.

Disclosure

All authors have declared no conflicts of interest.