Randomized Phase III Trial Comparing Single-Agent Paclitaxel Poliglumex (CT-2103, PPX) with Single-Agent Gemcitabine or Vinorelbine for the Treatment of PS 2 Patients with Chemotherapy-Naïve Advanced Non-small Cell Lung Cancer

O’Brien, Mary E. R. and Socinski, Mark A. and Popovich, Alexander Y. and Bondarenko, Igor N. and Tomova, Antoaneta and Bilynskyı, Borys T. and Hotko, Yevhen S. and Ganul, Valentin L. and Kostinsky, Ippolit Y. and Eisenfeld, Amy J. and Sandalic, Larissa and Oldham, Fred B. and Bandstra, Bruce and Sandler, Alan B. and Singer, Jack W. (2008) Randomized Phase III Trial Comparing Single-Agent Paclitaxel Poliglumex (CT-2103, PPX) with Single-Agent Gemcitabine or Vinorelbine for the Treatment of PS 2 Patients with Chemotherapy-Naïve Advanced Non-small Cell Lung Cancer. Journal of Thoracic Oncology, V. 3 (N 7). pp. 728-734. ISSN 1556-0864; 0307-0728

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Abstract

Background: Patients with advanced non-small cell lung cancer (NSCLC) and impaired performance status (PS ≥ 2) have limited life expectancies and decreased tolerance for drug-induced toxicities. Current treatment guidelines indicate that PS 2 patients benefit from systemic therapy. Further refinement of treatment in these patients requires reduction of treatment-associated toxicities while maintaining or improving efficacy. Paclitaxel poliglumex (PPX), a macromolecular polymer– drug conjugate of paclitaxel and poly-Lglutamic acid, may enhance the therapeutic index of paclitaxel. Methods: Chemotherapy-naive PS 2 patients with advanced NSCLC randomly received single-agent PPX (175 mg/m2 ) or a comparator (single-agent vinorelbine or gemcitabine). The primary end point of this study was overall survival. Results: Overall survival was similar between treatment arms (hazard ratio [HR] = 0.95; log-rank p = 0.686). Median and 1-year survival were 7.3 months and 26%, respectively, for PPX versus 6.6 months and 26% for the control arm. There was a nonsignificant trend toward improved survival in women in the PPX arm compared with standard single agents (HR = 0.65; p = 0.069). The most frequent grade 3/4 adverse events in the treatment versus control arm were dyspnea (13% versus 17%, respectively) and fatigue (10% versus 9%). Grade 3/4 neutropenia and anemia were reduced in the PPX arm (2% versus 8% and 3% versus 9%, respectively). Neuropathy, a taxane-specific toxicity, was more common in the PPX arm; grade 3 neuropathy was limited to 3%. Conclusions: Single-agent PPX, dosed at 175 mg/m2, is active and well tolerated in PS 2 patients with advanced NSCLC. Patients on PPX required fewer red blood cell transfusions, hematopoietic growth factors, opioid analgesics, and clinic visits than patients receiving gemcitabine or vinorelbine.

Item Type:	Article
Additional Information:	DOI: 10.1097/JTO.0b013e31817c6b68 Идентификационный номер: WOS:000257523900007 Идентификатор PubMed: 18594318
Uncontrolled Keywords:	Non-small cell lung cancer, Paclitaxel poliglumex, PPX, CT-2103, PS 2, Toxicity.
Subjects:	Oncology
Divisions:	Departments > Department of Oncology and Medical Radiology
Depositing User:	Елена Шрамко
Date Deposited:	01 Apr 2021 15:18
Last Modified:	01 Apr 2021 15:18
URI:	http://repo.dma.dp.ua/id/eprint/6396

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