Phase II trial of intraperitoneal cisplatin and mitoxantrone in patients with persistent ovarian cancer Journal Article
| Authors: | Husain, A.; Sabbatini, P.; Spriggs, D.; Fennelly, D.; Aghajanian, C.; Barakat, R.; Curtin, J.; Venkatraman, E.; Hoskins, W.; Markman, M. |
| Article Title: | Phase II trial of intraperitoneal cisplatin and mitoxantrone in patients with persistent ovarian cancer |
| Abstract: | Objective. The aim of this study was to determine the feasibility and efficacy of intraperitoneal cisplatin and mitoxantrone in patients with very small-volume residual disease at second-look surgery after completion of primary platinum-based intravenous chemotherapy. Patients and methods. Between February 1992 and February 1994, 42 patients were treated with up to five cycles of intraperitoneal cisplatin (100 mg/m2)/mitoxantrone (10 mg/m2). Patients were evaluated for surgically defined response rate and followed for progression-free (PFS) and overall survival (OS) using an intention-to-treat analysis, and grouped according to disease volume at initiation of treatment. Results. The mean age of all patients was 48.5 years. Thirty patients (71%) were Stage III at diagnosis; 18 patients (43%) had microscopic disease at the initiation of IP therapy, and 24 patients (57%) had macroscopic disease. Twenty-eight patients completed three or more cycles of protocol therapy, and 14 patients were changed to standard intravenous therapy after receiving fewer than three cycles of treatment secondary to catheter-related problems (12 patients), cisplatin ototoxicity (1 patient), or withdrawal from study (1 patient). Using an intention-to- treat analysis, the median PFS was 22.5 months, and the median OS of all patients (N = 42) was 47 months (6-72 months) with a median follow-up of 62.7 months. When grouped according to size of disease at initiation of treatment, the OS has not been reached at 62.7 months of follow-up in patients (N = 18) with microscopic disease. Conclusions. (1) The combination of IP mitoxantrone and cisplatin has an unacceptable catheter failure rate due to mitoxantrone toxicity; (2) PFS and OS is longer in patients with microscopic rather than macroscopic residual disease; and (3) intraperitoneal platinum-based chemotherapy in patients with very small-volume residual disease may result in improved survival. |
| Keywords: | adult; cancer chemotherapy; cancer survival; clinical article; treatment outcome; aged; middle aged; survival rate; treatment failure; clinical trial; drug tolerability; cisplatin; drug efficacy; antineoplastic agents; cancer staging; follow up; cancer grading; ovarian neoplasms; ovary cancer; phase 2 clinical trial; neoplasm recurrence, local; bone marrow suppression; antineoplastic combined chemotherapy protocols; abdominal pain; feasibility studies; disease progression; drug response; mitoxantrone; infusions, parenteral; intravenous drug administration; ototoxicity; catheter; intraperitoneal drug administration; humans; human; female; priority journal; article |
| Journal Title: | Gynecologic Oncology |
| Volume: | 73 |
| Issue: | 1 |
| ISSN: | 0090-8258 |
| Publisher: | Elsevier Inc. |
| Date Published: | 1999-04-01 |
| Start Page: | 96 |
| End Page: | 101 |
| Language: | English |
| DOI: | 10.1006/gyno.1998.5317 |
| PUBMED: | 10094887 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 16 August 2016 -- Source: Scopus |
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