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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

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dc.contributor.author조병철-
dc.date.accessioned2017-11-02T08:17:35Z-
dc.date.available2017-11-02T08:17:35Z-
dc.date.issued2017-
dc.identifier.issn0344-5704-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/154302-
dc.description.abstractBACKGROUND: 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.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherSpringer Verlag-
dc.relation.isPartOfCANCER CHEMOTHERAPY AND PHARMACOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHAntimetabolites, Antineoplastic/administration & dosage-
dc.subject.MESHAntineoplastic Agents/administration & dosage-
dc.subject.MESHAntineoplastic Agents, Phytogenic/administration & dosage-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols/administration & dosage-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols/adverse effects-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols/therapeutic use*-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung/drug therapy*-
dc.subject.MESHCisplatin/administration & dosage-
dc.subject.MESHDeoxycytidine/administration & dosage-
dc.subject.MESHDeoxycytidine/analogs & derivatives-
dc.subject.MESHDisease-Free Survival-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHKarnofsky Performance Status-
dc.subject.MESHLung Neoplasms/drug therapy*-
dc.subject.MESHMale-
dc.subject.MESHMaximum Tolerated Dose-
dc.subject.MESHMiddle Aged-
dc.subject.MESHTaxoids/administration & dosage-
dc.titleRandomized 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.typeArticle-
dc.publisher.locationGermany-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Internal Medicine-
dc.contributor.googleauthorJoungSoon Jang-
dc.contributor.googleauthorHoon-Kyo Kim-
dc.contributor.googleauthorByoung Chul Cho-
dc.contributor.googleauthorKyung Hee Lee-
dc.contributor.googleauthorHwan-Jung Yun-
dc.contributor.googleauthorIn Sook Woo-
dc.contributor.googleauthorHong Suk Song-
dc.contributor.googleauthorHun-Mo Ryoo-
dc.contributor.googleauthorChi-Hong Kim-
dc.contributor.googleauthorDer-Sheng Sun-
dc.contributor.googleauthorJong Wook Shin-
dc.identifier.doi10.1007/s00280-017-3289-6-
dc.contributor.localIdA03822-
dc.relation.journalcodeJ00437-
dc.identifier.eissn1432-0843-
dc.identifier.pmid28341958-
dc.identifier.urlhttps://link.springer.com/article/10.1007%2Fs00280-017-3289-6-
dc.subject.keywordCisplatin-
dc.subject.keywordDocetaxel-
dc.subject.keywordElderly patients-
dc.subject.keywordGemcitabine-
dc.subject.keywordNon-small cell lung cancer-
dc.contributor.alternativeNameCho, Byoung Chul-
dc.contributor.affiliatedAuthorCho, Byoung Chul-
dc.citation.titleCancer Chemotherapy and Pharmacology-
dc.citation.volume79-
dc.citation.number5-
dc.citation.startPage873-
dc.citation.endPage880-
dc.identifier.bibliographicCitationCANCER CHEMOTHERAPY AND PHARMACOLOGY, Vol.79(5) : 873-880, 2017-
dc.date.modified2017-11-01-
dc.identifier.rimsid42271-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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