Phase II study of "dose-dense" high-dose chemotherapy treatment with peripheral-blood progenitor-cell support as primary treatment for patients with advanced ovarian cancer Journal Article


Authors: Aghajanian, C.; Fennelly, D.; Shapiro, F.; Waltzman, R.; Almadrones, L.; O'Flaherty, C.; O'Conner, K.; Venkatraman, E.; Barakat, R.; Curtin, J.; Brown, C.; Reich, L.; Wuest, D.; Norton, L.; Hoskins, W.; Spriggs, D. R.
Article Title: Phase II study of "dose-dense" high-dose chemotherapy treatment with peripheral-blood progenitor-cell support as primary treatment for patients with advanced ovarian cancer
Abstract: Purpose: We performed a pilot phase II study to evaluate the potential for delivery of rapidly sequenced high-dose chemotherapy treatments rescued with autologous peripheral-blood progenitor cells (PBP) in patients with previously untreated, advanced ovarian cancer. Patients and Methods: A single cycle of mobilization was used, primed with cyclophosphamide (CPA)/paclitaxel (TxI) and filgrastim (granulocyte colony-stimulating factor [G-CSF]), followed by three cycles of high-dose carboplatin (CBDCA)/TxI and one cycle of high-dose melphalan (MEL), each rescued by PBP. We then analyzed the outcome for a total of 56 consecutive patients treated with high-dose chemotherapy as port of this program. Results: In the phase II pilot, 21 patients were enrolled. There were no treatment-related deaths through 98 high-dose treatments, although 34 treatments were complicated by hospitalization, primarily for neutropenic fever. Seventy-six percent of patients experienced grade 3 to 4 gastrointestinal toxicity and 62% experienced grade 2 to 3 neuropathy. Five of 15 (33%) patients who underwent second-look surgery attained a pathologic complete response. In the overall analysis, 56 patients were reviewed. Forty-four patients were assessable for response by second-look surgery or clinical progression. Fifteen of 44 patients a achieved a pathologic complete response (34%). The pathologic complete response rate in optimal-disease patients was 12 of 22 (55%), while only three of 22 (13%) suboptimal stage III and IV patients achieved a pathologic complete response. Conclusion: The Gynecologic Oncology Group has initiated a pilot phase II trial of this approach in patients with optimally debulked stage III ovarian cancer. There is no evidence to support the use of this or other aggressive regimens outside of a clinical trial.
Keywords: adult; cancer chemotherapy; cancer survival; clinical article; middle aged; survival rate; clinical trial; advanced cancer; drug efficacy; skin toxicity; paclitaxel; combined modality therapy; drug megadose; neurotoxicity; ovarian neoplasms; cd34 antigen; carboplatin; ovary cancer; phase 2 clinical trial; blood toxicity; antineoplastic combined chemotherapy protocols; lorazepam; cyclophosphamide; melphalan; hematopoietic stem cell transplantation; gastrointestinal toxicity; drug response; ciprofloxacin; vancomycin; recombinant granulocyte colony stimulating factor; granulocyte colony-stimulating factor; hematopoietic stem cell mobilization; intravenous drug administration; leukapheresis; subcutaneous drug administration; humans; human; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 16
Issue: 5
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1998-05-01
Start Page: 1852
End Page: 1860
Language: English
PUBMED: 9586901
PROVIDER: scopus
DOI: 10.1200/JCO.1998.16.5.1852
DOI/URL:
Notes: Article -- Export Date: 12 December 2016 -- Source: Scopus
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MSK Authors
  1. Venkatraman Ennapadam Seshan
    285 Seshan
  2. William Hoskins
    137 Hoskins
  3. Richard R Barakat
    588 Barakat
  4. Larry Norton
    562 Norton
  5. Carol Brown
    116 Brown
  6. David L Wuest
    27 Wuest
  7. John P Curtin
    74 Curtin
  8. David R Spriggs
    312 Spriggs
  9. Lilian M Reich
    68 Reich
  10. Lois Ann Cassidy
    30 Cassidy