Non Small Cell Lung Cancer

A phase II trial of Cremorphor EL free paclitaxel (Genexol PM) and gemcitabine in patients with advanced non small cell lung cancer


Hee Kyung Ahn • Minkyu Jung • Sun Jin Sym • Dong Bok Shin • Shin Myung Kang • Sun Young Kyung • Jeong Woong Park • Sung Hwan Jeong • Eun Kyung Cho

Received: 27 November 2013 / Accepted: 23 May 2014 / Published online: 7 June 2014 © The Author(s) 2014. This article is published with open access at

Purpose : Genexol-PM is a Cremorphor EL (CrEL)-free polymeric micelle formulation of paclitaxel that allows higher-dose administration with less hypersensitivity. This study was designed to evaluate the efficacy and safety of Genexol-PM and gemcitabine combination in advanced non-small cell lung cancer patients as a first-line treatment. Patients and methods This is a prospective, single-arm, single-center phase II study.

Patients with advanced NSCLC received Genexol-PM at 230 mg/m2 on day 1 and gemcitabine 1,000 mg/m2 on day 1 and day 8 of a 3-week cycle. Six cycles of chemotherapy were planned unless there was disease progression. The primary endpoint was overall response rate.

Results : Forty-three patients received the study drugs with a median of 4 cycles per patient (range 1–6). The overall response rate was 46.5 %. The median progression-free survival was 4.0 months (95 % CI 2.0–6.0 months), and median overall survival was 14.8 months (95 % CI 9.1– 20.5 months). The most common toxicities were anemia (n = 29, 67 %), asthenia (n = 17, 40 %), myalgia (n = 16, 37 %), peripheral neuropathy (n = 15, 35 %), and diarrhea

H. K. Ahn • M. Jung • S. J. Sym • D. B. Shin • E. K. Cho () Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, 1198 Guwol dong, Namdong gu, Incheon 405 760, Republic of Korea e-mail:

M. Jung, Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea

S. M. Kang • S. Y. Kyung • J.-W. Park • S. H. Jeong, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea

(n = 12, 30 %). The most common grade 3/4 adverse events were neutropenia (n = 7, 16 %) and pneumonia (n = 5, 12 %). Two patients died of pneumonia and dyspnea.

Conclusions : CrEL-free paclitaxel in combination with gemcitabine demonstrated favorable antitumor activity with little emetogenicities in non-small cell lung cancer patients. However, frequent grade 3/4 toxicities were observed, and safety should be evaluated thoroughly in future studies.

Keywords : Non-small cell lung cancer • Gemcitabine • Paclitaxel • Chemotherapy • Genexol-PM

Brand Name: PAXUS™ PM (South East Asia), GENEXOL® PM (Korea & other territories)