Phase II trial of weekly docetaxel and gemcitabine for previously untreated, advanced non-small cell lung cancer

Park, Se Hoon; Hong, Junshik; Kim, Young Saing; Kim, Yujin; Kyung, Sun Young; An, Chang Hyeok; Lee, Sang Pyo; Park, Jeong Woong; Jeong, Sung Hwan; Park, Jinny; Cho, Eun Kyung; Shin, Dong Bok; Lee, Jae Hoon

doi:10.1016/j.lungcan.2008.02.001

Cited by 6 publications

(1 citation statement)

References 28 publications

(41 reference statements)

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“…ORR , TTP, and OS were 20.4%, 3.6 months, 8.7 months respectively in DG arm versus 31.0%, 5.2 months, 9.4 months, respectively in arm Cis-Gem+Doc (P>0.05). Similarly, the other five phase II trials [17][18][19][20][21] reported no statistical difference in survival between the two regimens.…”

Section: Toxicitymentioning

confidence: 92%

Gemcitabine-docetaxel versus gemcitabine - cisplatin as first-line therapy in patients with advanced non-small cell lung cancer

Algizawy

Mostafa

2014

Kasr-Al-Aini J.of Clin. Onc. and Nuc. Med.

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Lung cancer is the leading cause of cancer deaths worldwide in men, and second most common in women. Worldwide, lung cancer occurred in approximately 1.8 million patients in 2012 and caused an estimated 1.6 million deaths 1. Non-small-cell lung cancer (NSCLC) represents more than 80% of lung cancer diagnoses and has an overall 5-year survival rate of approximately 16%, which decreases precipitously among patients diagnosed with late stage disease 2. Despite enthusiasm for the use of molecular testing and molecularly targeted agents in patients with advanced non-small cell lung cancer (NSCLC), most patients are not candidates for upfront treatment with molecular agents. Moreover, many candidate patients can't afford the vastly increased cost of such novel agents. Chemotherapy therefore remains the first-line treatment for most patients with stage IV non-small cell lung cancer (NSCLC) 3. Multiple individual randomised studies and several meta-analyses have shown a survival benefit for platinumbased chemotherapy compared with best supportive care in patients with good performance status 4,5 , but at the cost of severe toxicities. Combinations with better toxicity profile but with equal or improved efficacy are eagerly needed. Nonplatinum combinations have been tested and are considered alternative regimens for those who cannot tolerate platinum-based chemotherapy. Among these combinations, the combination of gemcitabine and docetaxel has emerged as one of the most promising, showing equivalent efficacy with, and less toxicity than, cisplatin-based chemotherapies 6 .

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Section: Toxicitymentioning

confidence: 92%

Gemcitabine-docetaxel versus gemcitabine - cisplatin as first-line therapy in patients with advanced non-small cell lung cancer

Algizawy

Mostafa

2014

Kasr-Al-Aini J.of Clin. Onc. and Nuc. Med.

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Pulmonary toxicity among cancer patients treated with a combination of docetaxel and gemcitabine: a meta-analysis of clinical trials

Binder

Hübner

Temmesfeld-Wollbrück

2011

Cancer Chemother Pharmacol

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

Ahn

Jung

Sym

et al. 2014

Cancer Chemother Pharmacol

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153

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PurposeGenexol-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 methodsThis 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.ResultsForty-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.ConclusionsCrEL-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.

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Phase II trial of weekly docetaxel and gemcitabine for previously untreated, advanced non-small cell lung cancer

Cited by 6 publications

References 28 publications

Gemcitabine-docetaxel versus gemcitabine - cisplatin as first-line therapy in patients with advanced non-small cell lung cancer

Gemcitabine-docetaxel versus gemcitabine - cisplatin as first-line therapy in patients with advanced non-small cell lung cancer

Pulmonary toxicity among cancer patients treated with a combination of docetaxel and gemcitabine: a meta-analysis of clinical trials

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

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