Iniparib plus paclitaxel and carboplatin as initial treatment of advanced or recurrent uterine carcinosarcoma: A Gynecologic Oncology Group Study Journal Article
| Authors: | Aghajanian, C.; Sill, M. W.; Secord, A. A.; Powell, M. A.; Steinhoff, M. |
| Article Title: | Iniparib plus paclitaxel and carboplatin as initial treatment of advanced or recurrent uterine carcinosarcoma: A Gynecologic Oncology Group Study |
| Abstract: | Objective: To estimate the activity and tolerability of iniparib plus paclitaxel and carboplatin as initial therapy of uterine carcinosarcoma. Methods: Eligible patients had advanced, persistent or recurrent carcinosarcoma of the uterus, measurable disease and no prior chemotherapy. Patients received paclitaxel 175 mg/m 2 IV over 3 h followed by carboplatin area under the curve (AUC) = six over 30 min on day one of 21 day cycles plus iniparib 4 mg/kg IV over 1 h twice weekly beginning on day one. Treatment continued until disease progression or adverse effects prohibited further therapy. Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was used to grade adverse events. The primary endpoint was tumor response. The study was conducted with a 2-stage group sequential design, targeting 20 and 25 patients in each stage. The study was designed to distinguish between 45% versus 65% responding with alpha = 10% and 90% power. Results: Twenty-two patients were entered onto the study with five excluded from analysis, leaving 17 evaluable for analysis. Treatment resulted in the expected hematologic and non-hematologic toxicities of the paclitaxel-carboplatin backbone. The observed proportion responding was 23.5% (4/17 patients). The two-sided, 90% confidence interval for the true probability of response was 8.5-46.1%. The required minimal number of responses to proceed to second stage was eight. Conclusions: Iniparib plus paclitaxel and carboplatin did not show significant activity to warrant further study. The rate of exclusion upon central pathology review (23%) suggests that review of pathology slides for confirmation of eligibility is important in this tumor type. © 2012 Elsevier Inc. All rights reserved. |
| Keywords: | adult; cancer chemotherapy; cancer survival; clinical article; treatment response; aged; aged, 80 and over; disease-free survival; middle aged; overall survival; neutropenia; advanced cancer; area under the curve; drug efficacy; paclitaxel; cancer radiotherapy; chemotherapy; cancer staging; nuclear magnetic resonance imaging; outcome assessment; recurrent cancer; carboplatin; progression free survival; computer assisted tomography; infection; pain; neoplasm recurrence, local; anemia; tumor volume; allergy; bleeding; heart disease; leukopenia; lung disease; nausea; thrombocytopenia; vomiting; antineoplastic combined chemotherapy protocols; laboratory test; skin disease; physical examination; eye disease; urogenital tract disease; neurologic disease; uterine neoplasms; gastrointestinal disease; metabolic disorder; musculoskeletal disease; endocrine disease; uterine cancer; hematologic disease; uterus carcinoma; carcinosarcoma; lymphatic system disease; benzamides; kaplan-meier estimate; iniparib; nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase 1; uterine carcinosarcoma |
| Journal Title: | Gynecologic Oncology |
| Volume: | 126 |
| Issue: | 3 |
| ISSN: | 0090-8258 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2012-09-01 |
| Start Page: | 424 |
| End Page: | 427 |
| Language: | English |
| DOI: | 10.1016/j.ygyno.2012.05.024 |
| PROVIDER: | scopus |
| PUBMED: | 22634397 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 4 September 2012" - "CODEN: GYNOA" - "Source: Scopus" |
