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Randomized phase II study comparing weekly docetaxel-cisplatin vs. gemcitabine-cisplatin in elderly or poor performance status patients with advanced non-small cell lung cancer
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2017-11-02T08:17:35Z | - |
dc.date.available | 2017-11-02T08:17:35Z | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 0344-5704 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/154302 | - |
dc.description.abstract | BACKGROUND: Docetaxel/cisplatin (DP) and gemcitabine/cisplatin (GP) are standard treatment regimens for advanced non-small cell lung cancer (NSCLC). In spite of potent efficacy, the conventional 1-day DP is regarded as having more toxicity as compared with GP. There is increasing interest in a biweekly split administration of DP to reduce its toxicity. Hypothesis was that first-line biweekly DP is as safe as GP in the elderly or poor performance status (PS) patients. METHODS: Chemotherapy-naïve patients with advanced NSCLC (IIIB/IV) who were elderly (65<) or PS (ECOG 2) were randomized to DP or GP arm by balancing for ECOG (0-1 vs. 2) and stage (IIIB vs. IV). DP comprised docetaxel (35 mg/m2)/cisplatin (30 mg/m2) iv on days 1 and 8, every 3 weeks. GP comprised gemcitabine (1000 mg/m2)/cisplatin (30 mg/m2) iv on days 1 and 8, every 3 weeks. Chemotherapy lasted up to 4-6 cycles or until progression. Primary endpoint was safety (proportion of grade 3/4 toxicities). Planned sample size was 49 patients in each arm. RESULTS: From November 2009 to August 2012, a total of 99 patients were randomized (DP 50/GP 49) from nine institutions. Adenocarcinoma and squamous cell carcinoma were observed in 62% and 33% of patients, respectively. Toxicity profiles were comparable for both arms and the differences were not statistically significant except for anemia and leucocytopenia. Any grade of anemia (86 vs. 98%) and of leucocytopenia (18 vs. 43%) was more common in the GP arm with statistical significance. Oral mucositis tended to be predominant in the DP arm. Patients in the DP arm (51%) suffered grade 3 or higher toxicities as did 47% in the GP arm (47%). The most common grade 3 or higher toxicities were as follows: In the DP arm, neutropenia (8%), leucopenia (8%), anemia (4%), pneumonia with normal ANC (4%) and febrile neutropenia (2%) were observed. In the GP arm, anemia (15%), neutropenia (15%), pneumonia with normal ANC (4%), thrombocytopenia (4%) and leucopenia (2%) were observed. The best overall response rates (CR + PR) for the DP and GP arms were 20.0 and 21% with no CR, respectively, and disease control rates (CR + PR + SD) were 70.0 and 76%, respectively. Median progression-free survival and median overall survival were 3.7 and 14.9 months in the DP arm and 5.6 and 20.8 months in the GP arm, respectively. CONCLUSION: This study showed that DP is similar to GP in terms of efficacy and toxicity in treatment of elderly or poor performance patients. Both regimens showed similar grade 3/4 toxicities with different profiles. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Springer Verlag | - |
dc.relation.isPartOf | CANCER CHEMOTHERAPY AND PHARMACOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Aged, 80 and over | - |
dc.subject.MESH | Antimetabolites, Antineoplastic/administration & dosage | - |
dc.subject.MESH | Antineoplastic Agents/administration & dosage | - |
dc.subject.MESH | Antineoplastic Agents, Phytogenic/administration & dosage | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/administration & dosage | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/therapeutic use* | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung/drug therapy* | - |
dc.subject.MESH | Cisplatin/administration & dosage | - |
dc.subject.MESH | Deoxycytidine/administration & dosage | - |
dc.subject.MESH | Deoxycytidine/analogs & derivatives | - |
dc.subject.MESH | Disease-Free Survival | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Karnofsky Performance Status | - |
dc.subject.MESH | Lung Neoplasms/drug therapy* | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Maximum Tolerated Dose | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Taxoids/administration & dosage | - |
dc.title | Randomized phase II study comparing weekly docetaxel-cisplatin vs. gemcitabine-cisplatin in elderly or poor performance status patients with advanced non-small cell lung cancer | - |
dc.type | Article | - |
dc.publisher.location | Germany | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | JoungSoon Jang | - |
dc.contributor.googleauthor | Hoon-Kyo Kim | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Kyung Hee Lee | - |
dc.contributor.googleauthor | Hwan-Jung Yun | - |
dc.contributor.googleauthor | In Sook Woo | - |
dc.contributor.googleauthor | Hong Suk Song | - |
dc.contributor.googleauthor | Hun-Mo Ryoo | - |
dc.contributor.googleauthor | Chi-Hong Kim | - |
dc.contributor.googleauthor | Der-Sheng Sun | - |
dc.contributor.googleauthor | Jong Wook Shin | - |
dc.identifier.doi | 10.1007/s00280-017-3289-6 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J00437 | - |
dc.identifier.eissn | 1432-0843 | - |
dc.identifier.pmid | 28341958 | - |
dc.identifier.url | https://link.springer.com/article/10.1007%2Fs00280-017-3289-6 | - |
dc.subject.keyword | Cisplatin | - |
dc.subject.keyword | Docetaxel | - |
dc.subject.keyword | Elderly patients | - |
dc.subject.keyword | Gemcitabine | - |
dc.subject.keyword | Non-small cell lung cancer | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | Cho, Byoung Chul | - |
dc.citation.title | Cancer Chemotherapy and Pharmacology | - |
dc.citation.volume | 79 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 873 | - |
dc.citation.endPage | 880 | - |
dc.identifier.bibliographicCitation | CANCER CHEMOTHERAPY AND PHARMACOLOGY, Vol.79(5) : 873-880, 2017 | - |
dc.date.modified | 2017-11-01 | - |
dc.identifier.rimsid | 42271 | - |
dc.type.rims | ART | - |
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