Paclitaxel, ifosfamide, and cisplatin efficacy for first-line treatment of patients with intermediate- or poor-risk germ cell tumors Journal Article

Authors: Feldman, D. R.; Hu, J.; Dorff, T. B.; Lim, K.; Patil, S.; Woo, K. M.; Carousso, M.; Hughes, A.; Sheinfeld, J.; Bains, M.; Daneshmand, S.; Ketchens, C.; Bajorin, D. F.; Bosl, G. J.; Quinn, D. I.; Motzer, R. J.
Article Title: Paclitaxel, ifosfamide, and cisplatin efficacy for first-line treatment of patients with intermediate- or poor-risk germ cell tumors
Abstract: Purpose Paclitaxel, ifosfamide, and cisplatin (TIP) achieved complete responses (CRs) in two thirds of patients with advanced germ cell tumors (GCTs) who relapsed after first-line chemotherapy with cisplatin and etoposide with or without bleomycin. We tested the efficacy of first-line TIP in patients with intermediate- or poor-risk disease. Patients and Methods In this prospective, multicenter, single-arm phase II trial, previously untreated patients with International Germ Cell Cancer Collaborative Group poor-risk or modified intermediate-risk GCTs received four cycles of TIP (paclitaxel 240 mg/m2 over 2 days, ifosfamide 6 g/m2 over 5 days with mesna support, and cisplatin 100 mg/m2 over 5 days) once every 3 weeks with granulocyte colonystimulating factor support. The primary end point was the CR rate. Results Of the first 41 evaluable patients, 28 (68%) achieved a CR, meeting the primary efficacy end point. After additional accrual on an extension phase, total enrollment was 60 patients, including 40 (67%) with poor risk and 20 (33%) with intermediate risk. Thirty-eight (68%) of 56 evaluable patients achieved a CR and seven (13%) achieved partial responses with negative markers (PR-negative) for a favorable response rate of 80%. Five of seven achieving PR-negative status had seminoma and therefore did not undergo postchemotherapy resection of residual masses. Estimated 3-year progression-free survival and overall survival rates were 72% (poor risk, 63%; intermediate risk, 90%) and 91% (poor risk, 87%; intermediate risk, 100%), respectively. Grade 3 to 4 toxicities consisted primarily of reversible hematologic or electrolyte abnormalities, including neutropenic fever in 18%. Conclusion TIP demonstrated efficacy as first-line therapy for intermediate- and poor-risk GCTs with an acceptable safety profile. Given higher rates of favorable response, progression-free survival, and overall survival compared with prior first-line studies, TIP warrants further study in this population. © 2016 by American Society of Clinical Oncology.
Journal Title: Journal of Clinical Oncology
Volume: 34
Issue: 21
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2016-07-20
Start Page: 2478
End Page: 2483
Language: English
DOI: 10.1200/jco.2016.66.7899
PROVIDER: scopus
PUBMED: 27185842
PMCID: PMC5320896
Notes: Article -- Export Date: 2 August 2016 -- Source: Scopus
Citation Impact
MSK Authors
  1. Sujata Patil
    497 Patil
  2. Dean Bajorin
    602 Bajorin
  3. Robert Motzer
    1076 Motzer
  4. Darren Richard Feldman
    269 Feldman
  5. Joel Sheinfeld
    241 Sheinfeld
  6. Manjit S Bains
    301 Bains
  7. George Bosl
    421 Bosl
  8. Amanda Hughes
    11 Hughes
  9. Kaitlin Marie Woo
    100 Woo
  10. Kristina Maureen Lim
    3 Lim