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
DOI/URL:
Notes: Article -- Export Date: 2 August 2016 -- Source: Scopus
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MSK Authors
  1. Sujata Patil
    365 Patil
  2. Dean Bajorin
    382 Bajorin
  3. Robert Motzer
    707 Motzer
  4. Darren Richard Feldman
    164 Feldman
  5. Joel Sheinfeld
    192 Sheinfeld
  6. Manjit S Bains
    219 Bains
  7. George Bosl
    248 Bosl
  8. Amanda Hughes
    10 Hughes
  9. Kaitlin Marie Woo
    97 Woo
  10. Kristina Maureen Lim
    3 Lim