Ahn, Hee Kyung; Jung, Minkyu; Sym, Sun Jin; Shin, Dong Bok; Kang, Shin Myung; Kyung, Sun Young; Park, Jeong-Woong; Jeong, Sung Hwan; Cho, Eun Kyung
Cancer chemotherapy and pharmacology
2014Aug ; 74 ( 2 ) :277-82.
PMID : 24906423
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Ahn, Hee Kyung -
Jung, Minkyu -
Sym, Sun Jin -
Shin, Dong Bok -
Kang, Shin Myung -
Kyung, Sun Young -
Park, Jeong-Woong -
Jeong, Sung Hwan -
Cho, Eun Kyung -
ABSTRACT
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/m(2) on day 1 and gemcitabine 1,000 mg/m(2) 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 (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.
Adenocarcinoma/*drug therapy/mortality/pathology; Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols/*therapeutic use; Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/pathology; Carcinoma, Squamous Cell/*drug therapy/mortality/pathology; Deoxycytidine/administration & dosage/analogs & derivatives; Female; Follow-Up Studies; Humans; Liposomes; Lung Neoplasms/*drug therapy/mortality/pathology; Male; Middle Aged; Nanoparticles/chemistry; Neoplasm Staging; Paclitaxel/administration & dosage; Prognosis; Prospective Studies; Survival Rate; Young Adult
MESH
Adenocarcinoma/*drug therapy/mortality/pathology, Adolescent, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/*therapeutic use, Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/pathology, Carcinoma, Squamous Cell/*drug therapy/mortality/pathology, Deoxycytidine/administration & dosage/analogs & derivatives, Female, Follow-Up Studies, Humans, Liposomes, Lung Neoplasms/*drug therapy/mortality/pathology, Male, Middle Aged, Nanoparticles/chemistry, Neoplasm Staging, Paclitaxel/administration & dosage, Prognosis, Prospective Studies, Survival Rate, Young Adult
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