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1.
Kyoichi Kaira Yoshio Tomizawa Reiko Yoshino Yosuke Miura Akihiro Yoshii Yasuki Iwasaki Yasuhiko Koga Akihiro Ono Takeshi Hisada Koichi Minato Koji Sato Toshifumi Kazama Shinichi Ishihara Kenya Kohyama Naoto Fueki Ryusei Saito Noriaki Sunaga 《Lung cancer (Amsterdam, Netherlands)》2013
Background
We conducted a phase II study to evaluate the efficacy and safety of S-1 plus cisplatin with bevacizumab followed by maintenance bevacizumab in patients with advanced non-squamous non-small cell lung cancer (NSCLC).Patients and methods
Chemotherapy-naïve patients received S-1 plus cisplatin with bevacizumab. S-1 (80 mg/m2) was administered orally twice daily for 14 days, cisplatin (60 mg/m2) on day 1, and bevacizumab (15 mg/kg) on day 1 and every 3 weeks for 4–6 cycles. Patients with an objective response or stable disease received maintenance bevacizumab every 3 weeks until disease progression.Results
Thirty patients were enrolled in this study. The median number of chemotherapy was four (range, 1–6 cycles), and the median number of bevacizumab alone was three (range, 1–31 cycles). The grade 3/4 toxicities were neutropaenia (23%), thrombocytopaenia (10%), febrile neutropaenia (3%), hypertension (17%), pneumonia (7%), and bowel perforation (3%). The objective response rate was 71% (95% CI, 55–88%) for a disease control rate of 100%. The median progression-free and overall survival times were 7.0 months and 20.0 months, respectively.Conclusions
S-1 plus cisplatin with bevacizumab is an active and well-tolerated regimen in patients with chemotherapy-naïve non-squamous NSCLC. 相似文献2.
de Carpeño JC Barón MG Aguiar J Chacón JI Feliu J García MJ Madroñal C Colmenarejo A Sánchez JJ Ordóñez A;Oncopaz Cooperative Group 《Cancer chemotherapy and pharmacology》2006,58(2):266-271
Purpose: Improving chemotherapeutic efficacy in non-small cell lung cancer (NSCLC) will require the development of new strategies to better use currently available agents. To assess the efficacy and safety of a biweekly regimen of cisplatin, gemcitabine and vinorelbine for advanced non-small-cell lung cancer. Methods: Patients with selected stage IIIb (pleural effusion)/stage IV NSCLC, performance status of 0–2 and normal organ function were eligible. Treatment consisted of cisplatin 100 mg/m2 on day 1 plus gemcitabine, 1,000 mg/m2 and vinorelbine 25 mg/m2 on days 1 and 15 every 28 days. Results: Of the 40 patients enrolled and assessable for response, there were five (12.5%) with confirmed complete response and 14 (35%) with a confirmed partial response for an overall response rate of 47.5%. Nine patients had stable disease while 12 (30%) progressed. Median progression-free survival and overall survival for all patients were 6.3 and 11.1 months, respectively. Toxicity was principally hematologic, with grade 3–4 neutropenia in 30%, and grade 3–4 nausea/vomiting in 22.5%. There were no treatment-related deaths. Conclusions: The biweekly regimen of cisplatin, gemcitabine and vinorelbine is associated with a high rate of response, lesser toxicity than other three-drug regimens and no benefit of survival. Therefore, the regimen under study may be an appealing alternative when considering other treatment modalities for advanced lung cancer, such as neoadjuvant therapy. 相似文献
3.
N. Reinmuth A. Meyer D. Hartwigsen C. Schaeper G. Huebner R. Skock-Lober A. Bier U. Gerecke C.-P. Held M. Reck 《Lung cancer (Amsterdam, Netherlands)》2014
Objectives
Adding nitroglycerin to the combination of vinorelbine plus cisplatin has been reported to improve the overall survival (OS) of Asian patients with stage IIIB/IV non-small cell lung cancer (NSCLC) probably due to better drug delivery based on changed vascular tonus. The main objective of our study was to evaluate the effect of adding nitroglycerin to vinorelbine and cisplatin in a Caucasian population.Methods
66 chemonaïve patients with stage IIIB/IV NSCLC received oral vinorelbine (first cycle 60 mg/m2, subsequent cycles: 80 mg/m2 in the absence of any hematological toxicity ≥grade 3 in cycle 1) once daily on days 1 and 8 of each cycle and cisplatin (80 mg/m2 i.v.) on day 1 of each cycle (q3w). Nitroglycerin (arm A, n = 34) or placebo patches (arm B, n = 32) were administered once daily from day −3 to day 2 of each cycle and were removed about 12 h after administration. One nitroglycerin patch contained 25 mg nitroglycerin.Results
Median age was 62.5 (33–82) years. In the overall population (n = 66), the objective response rate (ORR) was 27.3% (all PR; 95%CI: 17.0–39.6), with a disease control rate (DCR) of 57.6% (95%CI: 44.8–69.7), a median time to progression (TTP) of 4.8 months (n = 58; 95%CI: 3.4–5.9) and a median overall survival (OS) of 11.5 months (95%CI: 7.9–13.6). ORR and DCR were numerically higher in arm A than in arm B (35.3% vs. 18.8% and 61.8% vs. 53.1%, respectively), whereas TTP and OS were comparable. The main hematological and non-hematological toxicities grade ≥3 were moderate with no significant differences between the two treatment arms.Conclusions
Overall, oral vinorelbine plus cisplatin showed a high level of efficacy and adequate tolerability in first line treatment of NSCLC. Despite the low sample size per group the results seem to confirm the previous results reported in Asian patients. 相似文献4.
Wolfgang H.W. Schuette Andreas Gröschel Martin Sebastian Stefan Andreas Thomas Müller Folker Schneller Sylvia Guetz Corinna Eschbach Sabine Bohnet Monika I. Leschinger Martin Reck 《Clinical lung cancer》2013,14(3):215-223
BackgroundPemetrexed plus cisplatin was approved for first-line treatment of non–small-cell lung cancer (NSCLC) in patients with nonsquamous histology after initiation of this study. This phase II study evaluated pemetrexed plus cisplatin and pemetrexed plus carboplatin as first-line treatments for stage IIIB/IV NSCLC.Patients and MethodsThe patients were randomized (1:1) to 2 parallel arms: pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or pemetrexed (500 mg/m2) plus carboplatin (area under the curve 6) day 1 every 3 weeks (maximum, 6 cycles). Progression-free survival (PFS) was the primary objective; secondary objectives included overall survival (OS), 1-year survival, and safety.ResultsSixty-five patients were randomized to each treatment arm. The patients treated with pemetrexed plus cisplatin had a median age of 64 years and were predominantly men (42 [64.6%]) with nonsquamous histology (53 [81.5%]), stage IV (61 [92.4%]) disease, and a performance status of 0 (40 [61.5%]). Median PFS was 6.0 months, 6-month PFS rate was 50.5%, median OS was 11.7 months, and 1-year survival rate was 47.5%. Drug-related grade 3/4 toxicities included neutropenia (11 [16.9%]), anemia (5 [7.7%]), thrombocytopenia (2 [3.1%]), and nausea (3 [4.6%]). Patients treated with pemetrexed plus carboplatin had a median age of 63 years, were predominantly men (46 [70.8%]) with nonsquamous histology (52 [80.0%]), stage IV (58 [86.6%]) disease, and a performance status of 0 (45 [69.2%]). The median PFS was 4.7 months, the 6-month PFS rate was 34.9%, median OS was 8.9 months, and 1-year survival rate was 39.2%. Drug-related grade 3/4 toxicities included neutropenia (17 [26.2%]), thrombocytopenia (11 [16.9%]), anemia (7 [10.8%]), and nausea (5 [7.7%]).ConclusionsBoth the pemetrexed plus cisplatin and pemetrexed plus carboplatin arms met their primary endpoints and demonstrated efficacy and tolerability as first-line therapy in patients with advanced NSCLC. http://ClinicalTrials.gov: NCT00402051. 相似文献
5.
Weekly gemcitabine and cisplatin combination therapy in patients with transitional cell carcinoma of the urothelium: A phase II clinical trial 总被引:3,自引:3,他引:0
H. von der Maase L. Andersen L. Crinò S. Weinknecht L. Dogliotti 《Annals of oncology》1999,10(12):1461-1465
Purpose: To determine the efficacy of gemcitabine and cisplatin combination therapy in patients with advanced and/or metastatic transitional cell urothelial carcinoma.Patients and methods: Forty-two chemonaïve patients with Karnofsky performance status (KPS) 70 were treated with cisplatin 35 mg/m2 followed by gemcitabine 1000 mg/m2 (30 min i.v. infusion) on days 1, 8, and 15 every twenty-eight days.Results: Thirty-eight patients were evaluable for efficacy. Half had visceral disease. There were seven complete (18%) and nine partial responses (24%), for a response rate of 42% (95% confidence interval (95% CI): 26%–59%). Responses were independently reviewed. Median response duration was 13.5 months (95% CI: 8.5–18.1 months), median time to progressive disease 7.2 months (95% CI: 4.0–9.1 months) and median survival 12.5 months (95% CI: 8.1–18.7 months); one-year survival was 52%. Laboratory toxicities included leucopenia (44% grade 3; 17% grade 4), neutropenia (25% grade 3; 33% grade 4) and thrombocytopenia (29% grade 3; 49% grade 4). Four patients had grade 4 symptomatic toxicity (three nausea and vomiting, one diarrhoea). There were no grade 4 infections and no toxic deaths.Conclusions: The combination of gemcitabine and cisplatin is active in patients with locally advanced and/or metastatic urothelial carcinoma. The weekly schedule of cisplatin is considered inappropriate. 相似文献
6.
Guan-Zhong Zhang Shun-Chang Jiao Zhao-Ting Meng 《Journal of experimental & clinical cancer research : CR》2010,29(1):38
Background
The objective of this study was to evaluate the efficacy and safety of pemetrexed plus cisplatin/carboplatin in locally advanced or metastatic non-small cell lung cancer (NSCLC) patients previously treated with platinum-based chemotherapy.Methods
Fifty-three locally advanced or metastatic non-small cell lung cancer patients previously treated with platinum-based chemotherapy received pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 or carboplatin area under the curve (AUC) 5 every 21 days, with dexamethasone, folic acid and vitamin B12 being administered.Results
Median age was 52 years. Eastern Cooperative Oncology Group (ECOG) performance status was 0-2. Thirty-eight patients had stage IV tumors. Thirty-seven patients had adenocarcinoma (including 6 alveolar carcinoma patients), and fourteen patients had squamous cell carcinoma. Thirty-four patients were treated in second line, 15 in third line, and 4 in fourth line. Seven patients (13.2%) showed partial response; Thirty-six (67.9%) had stable disease. The median progression free survival time was 6.0 months and the median overall survival time was 10.0 months. The 1-year survival rate was 40.9%. Five (9.4%) and four (7.5%) patients experienced grade 3 or 4 leukopenia and thrombocytopenia, respectively. Nonhematological toxicities included grade 3 nausea/vomiting in 1 patient (1.9%), grade 3 rash in 1 patient, grade 4 diarrhea in 1 patient (1.9%) and grade 4 creatinine increase in 1 patient (1.9%).Conclusion
Locally advanced or metastatic NSCLC patients previously treated with platinum-based chemotherapy could benefit from pemetrexed plus cisplatin/carboplatin chemotherapy with tolerable adverse events. 相似文献7.
V. Georgoulias N. Androulakis A. M. Dimopoulos C. Kourousis S. Kakolyris E. Papadakis F. Apostolopoulou C. Papadimitriou A. Vossos M. Agelidou P. Heras S. Tzannes J. Vlachonicolis E. Mavromanolakis D. Hatzidaki 《Annals of oncology》1998,9(3):331-334
Purpose: To evaluate the efficacy and safety of the docetaxel-cisplatin combination in patients with advanced non-small-cell lung cancer (NSCLC).Patients and methods: Chemotherapy-naïve patients with histologically confirmed, measurable stage IIIB or IV NSCLC, a World Health Organization (WHO) performance status of 0–2 and adequate bone marrow, renal, hepatic and cardiac function were eligible for the study. Patients received docetaxel (100 mg/m2) as an one-hour infusion on day 1 and cisplatin (80 mg/m2) as a 30-min infusion with appropriate hydration on day 2. Granulocyte colony-stimulating factor (G-CSF; 150 µg/m2 , SC) was given on days 3 to 13. Treatment was repeated every three weeks.Results: Fifty-three patients were enrolled (28 with stage IIIB and 25 with stage IV). One complete and 23 partial responses were observed (overall response rate (OR): 45%; 95% CI: 34.1%–61.8%). The response rate was 57% and 32% in patients with stages IIIB and IV disease (P = NS). The median time to progression was 36 weeks and the median survival 48 weeks; the one-year survival was 48%. Grade 3–4 neutropenia occurred in 23 patients, 15 of whom were hospitalized for neutropenic fever; two patients died of sepsis. Grade 2 neurotoxicity was observed in six patients and grade 3 in five patients; grade 3 fatigue occurred in seven patients, grade 3–4 mucositis in four patients and grade 3–4 diarrhea in six patients. Mild allergic reactions and oedema were observed in five and four patients, respectively. The median dose intensity was 30 mg/m2 /week for docetaxel and 24 mg/m2 /week for cisplatin, corresponding to 91% and 89% of the specified protocol doses, respectively.Conclusions: The docetaxel–cisplatin combination is an active regimen in advanced NSCLC, but hematologic toxicity remains high despite the prophylactic use of G-CSF. 相似文献
8.
Carmelo Tibaldi Enrica Mazzoni Giandomenico Arcabasso Armida D'Incecco Andrea Antonuzzo Gianfranco Menconi Alfredo Falcone 《Clinical lung cancer》2009,10(1):53-57
BackgroundThe combination cisplatin/gemcitabine is one of the most active and well-tolerated regimens in advanced non–small-cell lung cancer (NSCLC). We undertook this pilot study to evaluate postoperative drug delivery and toxicity of cisplatin plus gemcitabine in patients with radically resected stage IB-III NSCLC.Patients and MethodsTwenty-two consecutive patients were treated with cisplatin 80 mg/m2 on day 1 and gemcitabine 1200 mg/m2 on days 1 and 8 every 3 weeks for 4 planned courses. Most patients (50%) had pathologic stage IIIA disease; all had an Eastern Cooperative Oncology Group performance status score of 0 or 1. The median age was 63 years (range, 56-73 years). Six out of 22 patients (27.3%) had undergone pneumonectomy.ResultsA total of 85 courses of chemotherapy were administered, and the median number of courses was 4 (range, 1-4 courses); twenty-one out of 22 patients received the planned 4 courses of chemotherapy. Chemotherapy caused grade 3 anemia in 1 patient, grade 3 thrombocytopenia in another patient, and grade 3/4 neutropenia in 4 patients; grade 3 vomiting was observed in 3 patients, and grade 3 anorexia and grade 3 asthenia were both observed in 1 patient. No treatment-related deaths occurred. The median delivered dose intensities of cisplatin and gemcitabine were 24.3 mg/m2/week (97.2%) and 700.9 mg/m2 weekly (87.5%), respectively.ConclusionThe combination of cisplatin/gemcitabine is a feasible and well-tolerated regimen in the adjuvant setting. Future trials should better define the best strategy in terms of efficacy, toxicity, and quality of life between this combination and the standard regimen, cisplatin plus vinorelbine. 相似文献
9.
《Annals of oncology》2015,26(7):1401-1408
BackgroundPlatinum-based two-drug combination chemotherapy has been standard of care for patients with advanced nonsmall-cell lung cancer (NSCLC). The primary aim was to compare overall survival (OS) of patients with advanced NSCLC between the two chemotherapy regimens. Secondary end points included progression-free survival (PFS), response, safety, and quality of life (QoL).Patients and methodsPatients with previously untreated stage IIIB or IV NSCLC, an Eastern Cooperative Oncology Group performance status of 0–1 and adequate organ function were randomized to receive either oral S-1 80 mg/m2/day on days 1–21 plus cisplatin 60 mg/m2 on day 8 every 4–5 weeks, or docetaxel 60 mg/m2 on day 1 plus cisplatin 80 mg/m2 on day 1 every 3–4 weeks, both up to six cycles.ResultsA total of 608 patients from 66 sites in Japan were randomized to S-1 plus cisplatin (n = 303) or docetaxel plus cisplatin (n = 305). OS for oral S-1 plus cisplatin was noninferior to docetaxel plus cisplatin [median survival, 16.1 versus 17.1 months, respectively; hazard ratio = 1.013; 96.4% confidence interval (CI) 0.837–1.227]. Significantly higher febrile neutropenia (7.4% versus 1.0%), grade 3/4 neutropenia (73.4% versus 22.9%), grade 3/4 infection (14.5% versus 5.3%), and grade 1/2 alopecia (59.3% versus 12.3%) were observed in the docetaxel plus cisplatin than in the S-1 plus cisplatin. There were no differences found in PFS or response between the two arms. QoL data investigated by EORTC QLQ-C30 and LC-13 favored the S-1 plus cisplatin.ConclusionOral S-1 plus cisplatin is not inferior to docetaxel plus cisplatin and is better tolerated in Japanese patients with advanced NSCLC.Clinical trial numberUMIN000000608. 相似文献
10.
S. C. White H. Anderson G. C. Jayson L. Ashcroft M. Ranson N. Thatcher 《Annals of oncology》2000,11(2):201-206
Background:A randomised phase II study was performed to comparestandard combination chemotherapy containing cisplatin and etoposide withinfusional carboplatin.
Patients and methods:One hundred twenty patients with locallyadvanced/metastatic non-small-cell lung cancer or mesothelioma were enrolled.All were chemotherapy-naïve and had a Karnofsky performance status of50. Patients were randomised to either four cycles of bolus therapy ofcisplatin 80 mg/m2 day 1, etoposide 120 mg/m2 day1–3, or continuous infusion of carboplatin 100/mg/m2/week forsix weeks.
Results:No patients on infusional therapy incurred grade3–4 toxicity while in the bolus arm, grade 3 and grade 4 leucopeniaoccurred in 17% and 35% of patients, respectively. Grade 4thrombocytopenia occurred in 8% of patients and there were twoinstances of grade 3 renal toxicity. No responses occurred in the pump arm.Eight of forty-six patients with non-small-cell lung cancer responded totreatment (response rate 17.3%) with two complete responses and sixpartial responses. Only one patient with mesothelioma responded to bolustherapy. There was no difference in survival for the subset of NSCLC patients.Survival for mesothelioma patients in the pump arm was superior but this waslikely to be a result of early deaths in the bolus arm.
Conclusions:The pump arm was well-tolerated but not active,whilst combination platinum-based therapy demonstrated activity butsignificantly more toxicity than the pump arm. Further studies of infusionalcarboplatin with this schedule are not warranted. 相似文献
11.
Manuel Cobo-Dols Silvia Gil-Calle Esther Villar-Chamorro Inmaculada Alés-Díaz Francisco Carabantes-Ocón Julia Alcalde-García Vanesa Gutiérrez-Calderón Álvaro Montesa-Pino Juan J. Bretón-García Manuel Benavides-Orgaz 《Clinical & translational oncology》2006,8(7):519-524
Backbround In this Phase I/II trial, the maximum-tolerated dose (MTD) and activity of cisplatin plus vinorelbine (VRL) administered in
continuous in-fusion as first-line treatment of advanced non small cell lung cancer (NSCLC) was determined in 12 consecutive
chemotherapy-naive patients with advanced NSCLC.
Patients and methods The dose of cisplatin was 100 mg/m2 in all patients, and vinorelbine was administered as an initial intravenous (iv) bolus of 8 mg/m2 on day 1 followed by a 4-day continuous iv infusion at 4 different 24 h dose levels (DLs) to be repeated every 21 days. All
12 patients (47 cycles) were evaluable for response and toxicity.
Results The MTD was 8 mg/m2 bolus followed by a continuous iv infusion of 8 mg/m2 per day over 4 days. The dose limiting toxicities (DLT) were febrile neutropenia in 4 patients and grade 3 mucositis in 1
patient. There was less neuro-toxicity and compared to the weekly bolus scheme. There was no significant cumulative toxicity
after 3 cycles. Partial responses were observed in 6 patients; an overall response rate of 50% (95% CI: 30–65%). Median time
to progression was 5,5 months (95% CI: 1,5–11 months) and median survival was 11 months (95% CI: 5–20 months).
Conclusions The results demonstrate that, in this setting of first-line treatment of NSCLC, cisplatin plus vinorelbine at 8 mg/m2 bolus followed by a continuous infusion of 8 mg/m2 per day over 4 days is the recommended schedule. Further trials would be useful to establish activity of this combination. 相似文献
12.
N. Kentepozidis P. Economopoulou Ch. Christofyllakis L. Chelis A. Polyzos N. Vardakis F. Koinis L. Vamvakas P. Katsaounis K. Kalbakis Ch. Nikolaou V. Georgoulias A. Kotsakis 《Clinical & translational oncology》2017,19(3):317-325
Background
Platinum-based chemotherapy is the standard front-line treatment for patients with advanced non-small cell lung cancer (NSCLC). However, non-platinum combinations of third-generation chemotherapeutic agents are considered an alternative therapeutic option for patients who cannot tolerate the toxic effects of platinum compounds. In this study, the efficacy and toxicity of the combination of irinotecan plus cisplatin (IC) was compared to pemetrexed plus cisplatin (PC) regimen, in platinum-naïve patients with advanced NSCLC, who had been previously treated with the combination of a taxane plus gemcitabine.Patients and methods
A total of 124 patients with locally advanced or metastatic NSCLC were randomly assigned to either irinotecan 110 mg/m2 on day 1 and 100 mg/m2 on day 8 plus cisplatin 80 mg/m2 on day 8 every 3 weeks (IC arm) or pemetrexed 500 mg/m2 plus cisplatin 80 mg/m2 on day 1 every 3 weeks (PC arm). The primary endpoint of the study was the overall response rate (ORR).Results
The ORR and median progression-free survival (PFS) in the IC arm were 18 % and 3.3 months, respectively, while in the PC arm were 19 % and 4.2 months (p = ns). Median overall survival (OS) was significantly higher in patients with PC (6.9 vs. 10.9; p = 0.013). PC regimen had a better toxicity profile compared to IC, with a statistically significant lower incidence of grade 3/4 neutropenia (3 vs. 31 %; p = 0.0001) and diarrhea (1.6 vs. 14.7 %, p = 0.018).Conclusions
In patients with advanced NSCLC pretreated with docetaxel/gemcitabine, the combination of pemetrexed/cisplatin is associated with increased OS and is better tolerated than the combination of irinotecan/cisplatin and should be considered as a valid therapeutic option for platinum-naive, previously treated patients.ClinicalTrials.gov Identifier
NCT00614965.13.
Kiyoshi Mori Suguru Machida Takeshi Yoshida Munehide Yoshida Yasuliko Kano Keigo Tominaga 《Cancer chemotherapy and pharmacology》1999,43(6):467-470
Purpose: We administered chemotherapy consisting of a combination of 5-day continuous infusion of cisplatin (20 mg/m2 per day) plus irinotecan (160 mg/m2 per day, as a bolus, on day 1) with recombinant human granulocyte colony-stimulating factor (rG-CSF) support to previously
untreated advanced non-small-cell lung cancer (NSCLC) patients, and evaluated the effectiveness and safety of this therapy.
Patients: Enrolled in the study were 41 NSCLC patients. Results: Of the 41 patients, 24 achieved a partial response. The response rate was 58.5% (95% confidence interval, 42.2% to 74.8%),
with a median response duration of 32.1 weeks. The median survival time was 44.8 weeks and the 1-year survival rate was 44%.
A total of 100 courses of therapy were given. The major toxic effects were grade 3 or 4 diarrhea (23%), granulocytopenia (20%),
thrombocytopenia (15%) and anemia (15%). There were no treatment-related deaths. Conclusions: Combination chemotherapy with irinotecan plus infusional cisplatin with rG-CSF support was well tolerated and effective
in patients with advanced NSCLC.
Received: 4 May 1998 / Accepted: 18 September 1998 相似文献
14.
M. Rinaldi L. Crinò G. V. Scagliotti A. M. Mosconi F. De Marinis C. Gridelli G. Selvaggi M. Della Giulia S. Darwish S. Porrozzi S. Novello A. Cipri R. Bartolucci C. Calandri M. Tonato 《Annals of oncology》2000,11(10):1295-1300
Background:To explore a new schedule ofgemcitabine–cisplatin (GP) combination therapy using two differentcisplatin doses in patients with advanced non-small-cell lung cancer (NSCLC).
Patients and methods:From May to December 1997, 92 chemonaivepatients entered the study and 88 (28 with locally advanced and 60 withdisseminated NSCLC) were evaluable for response and toxicity (45 in arm A and43 in arm B). Patients were randomly assigned to arm A or arm B. Gemcitabine1000 mg/m2 was given on days 1–8 plus cisplatin 100mg/m2 in arm A and cisplatin 70 mg/m2 in arm B on day2 of every 21-day cycle.
Results:The overall response rates in arms A and B were42% (95% confidence interval (CI):27.8%–56.7%) and 47% (95% CI:31.6%–61.5%), respectively. Median duration of responsewas 9.7 months (range 1.8 to 30.9 months; 13.1 and 9.5 months for arm A andB, respectively), and median survival was 12 months (range 0.2 to 31.1 months;15.4 and 11.5 months for arm A and B, respectively). Major WHO grade 3–4toxicities in arm A vs. arm B included: thrombocytopenia (23% vs.17% of courses), leukopenia (15% vs. 4% of courses),anemia (7% vs. 6% of courses), and nausea-vomiting (20%vs. 7% of patients). Grade 1–2 nephrotoxicity occurred in20% of patients in arm A and in 7% of patients in arm B, withone grade 4 episode in arm A. Six patients discontinued treatment because oftoxicities, 5 in arm A and 1 in arm B.
Conclusions:Results of this trial indicate that both schedulesare feasible and active, with a milder toxicity in the arm with the lowercisplatin dose. 相似文献
15.
Aydiner A Sen F Saglam EK Oral EN Eralp Y Tas F Toker A Dilege S 《Clinical lung cancer》2011,12(5):286-292
Background
The main goal of this study was to evaluate the feasibility and effectivity of triweekly docetaxel/cisplatin followed by weekly docetaxel/cisplatin concomitantly with radiotherapy with or without surgery in locally advanced non–small-cell lung cancer (NSCLC) patients.Materials and Methods
Thirty five patients with locally advanced NSCLC were enrolled. Combination chemotherapy with triweekly docetaxel/cisplatin (75 mg/m2) was administered as induction regimen. After induction chemotherapy, patients were evaluated for surgery if their disease subsequently downstaged. Six cycles of weekly docetaxel/cisplatin (20 mg/m2) concurrently with radiotherapy up to a 60 Gy were administered after induction chemotherapy with or without surgery. Response, toxicity, time-to-progression and overall survival were evaluated.Results
Twelve patients with stage IIIA-N2 and 23 patients with stage IIIB-T4N0-2 were evaluated (median age, 54 years). After 94 cycles of induction chemotherapy, partial response was achieved in 20 patients, 9 patients had stable disease and six had progressive disease. After overall treatment, 6 patients achieved complete response, 19 patients had partial response, 8 patients had progressive disease, and 2 patients had stable disease. Two patients experienced grade 3-4 pulmonary toxicity and 1 patient experienced grade 3 esophageal toxicity. Six patients underwent surgery. Median overall survival for all patients was 15 months and time-to-progression was 13 months with a median follow-up of 22 months.Conclusion
Triweekly docetaxel plus cisplatin followed by weekly docetaxel plus cisplatin concomitantly with radiotherapy is effective and feasible and seems to be an alternative option for patients who have locally advanced NSCLC. Surgery may provide additional benefit for patients whose disease adequately downstaged after induction chemotherapy. 相似文献16.
Hirose T Mizutani Y Ohmori T Ishida H Hosaka T Ando K Shirai T Okuda K Ohnishi T Horichi N Kubota H Adachi M 《Cancer chemotherapy and pharmacology》2006,58(3):361-367
Aims: The aims of this study were to assess the efficacy and toxicity of concurrent chemoradiotherapy with divided schedule of cisplatin and vinorelbine in patients with locally advanced non-small-cell lung cancer (NSCLC). Methods: Patients with previously untreated, unresectable, and stage IIIA or IIIB NSCLC were eligible if they had a performance status of 0 or 1, were 75 years or younger, and had adequate organ function. Twenty-six patients (24 men and 2 women; median age, 66 years; age range, 42–75 years) were enrolled. Both cisplatin (40 mg/m2) and vinorelbine (20 mg/m2) were given on days 1 and 8 every 3 weeks. Beginning on day 2 of chemotherapy, thoracic radiotherapy was given for approximately 6 weeks (2 Gy per fraction; total dose, 60 Gy). Results: Five of the 26 patients achieved a complete response, and 16 achieved a partial response for an overall response rate of 80.8% (95% confidence interval, 60.6–93.4%). The median survival time was 23 months (range, 4–43 months). Overall survival rates at 1 and 2 years were 80 and 56%, respectively. Hematologic toxicities included grade 3–4 neutropenia in 84.6% of patients, grade 3–4 thrombocytopenia in 3.8%, and grade 3–4 anemia in 61.5%. Two patients (7.7%) had grade 3 radiation esophagitis that resolved completely without dilation. Grade 3–4 radiation pneumonitis occurred in two patients (7.7%) and was treated with corticosteroids. Both patients had a good partial resolution of symptoms and radiographic abnormalities. There were no treatment-related deaths. The actual delivered dose intensities for both cisplatin and vinorelbine were 79.5%. Radiotherapy was completed in 96% of patients. Conclusion: Concurrent chemoradiotherapy with cisplatin and vinorelbine administered on a divided schedule is effective and well tolerated in patients with locally advanced NSCLC. 相似文献
17.
T. De Pas F. de Braud R. Danesi C. Sessa C. Catania G. Curigliano S. Fogli M. del Tacca G. Zampino A. Sbanotto A. Rocca S. Cinieri E. Marrocco A. Milani A. Goldhirsch 《Annals of oncology》2000,11(7):821-827
Background:Gemcitabine (GEM) and paclitaxel (TAX) are active,non-cross-resistant drugs in non-small-cell lung cancer (NSCLC). We performeda phase I study to determine the maximum-tolerated dose (MTD), antitumoractivity and pharmacokinetics of GEM and TAX given weekly in chemo-naïvepatients with advanced NSCLC.
Patients and methods:Escalating doses of GEM (800–2000mg/m2) and TAX (60–100 mg/m2) were administeredon days 1, 8, 15 every 4 weeks to 35 patients with advanced NSCLC. Plasmapharmacokinetics of TAX and GEM was assessed at the three higher dose-levels.
Results:Dose-escalation was discontinued in absence of MTDbecause of increased cumulative toxicity leading to dose modification ortreatment delay at levels 6 and 7 (TAX 100 mg/m2 plus GEM 1750 and,respectively, 2000 mg/m2). Hematological toxicity included grade4 neutropenia in 3% of cycles, grade 3 thrombocytopenia in one cycleand febrile neutropenia in three cycles. Maximal non-hemathological toxicitywas grade 3 elevation in serum transaminases and grade 2 neuro-sensorytoxicity in 8% and 5% of cycles, respectively. At the two higherdose-levels a non-linear pharmacokinetics of GEM was observed with aremarkable variability of Cmax and AUC. No pharmacokineticinteractions were reported. Objectives responses were seen at all dose levels,with an overall response rate of 43% (95% confidence interval(95% CI): 25.5%–62.6%) in 30 evaluable patients.
Conclusions:The weekly administration of GEM and TAX is very welltolerated, and has shown promising antitumor activity in NSCLC. In view of thecumulative toxicity and of the pharmacokinetic profile of GEM, doses of 1500mg/m2 of GEM and 100 mg/m2 of TAX are recommended forphase II studies. 相似文献
18.
S. Kakolyris C. Kouroussis K. Kalbakis D. Mavroudis J. Souglakos N. Vardakis S. Kremos V. Georgoulias 《Annals of oncology》2000,11(6):757-760
Background:A phase II study was conducted in order to determinethe toxicity and efficacy of the combination of CPT-11 and cisplatin, assalvage treatment in patients with advanced non-small-cell lung cancer(NSCLC), progressing after a docetaxel-based front-line regimen.
Patients and methods:Thirty-one patients (median age 61 years)with NSCLC, were enrolled. Twenty-six (84%) patients were male,twenty-five (81%) had disease stage IV, and twenty-eight (90%)had a performance status (WHO) 0–1. CPT-11 was administered as a60-minute i.v. infusion at the dose of 100 mg/m2 on day 1 and 110mg/m2 on day 8; cisplatin was administered at the dose of 80mg/m2 on day 8, after CPT-11 administration. Treatment was repeatedevery three weeks.
Results:A total of 110 chemotherapy cycles were administered. Inan intention-to-treat analysis 7 patients (23%; 95% confidenceinterval (95% CI): 8%–37%) achieved a partialresponse, 6 (19%) had stable disease, and 18 (58%) progressivedisease. Three of responders had failed a previous docetaxel–carboplatincombination. The median duration of response was 3 months, the median TTP 8months and the median survival for the entire group 8 months. Grade 3–4neutropenia was observed in 16 (52%) patients and in two cases this wasfebrile. Grade 3 and 4 thrombocytopenia occurred in two (7%) patients,respectively. Grade 3 and 4 diarrhea was seen in 10 (33%) patients,grade 2–3 neurotoxicity in 2 (6%), and fatigue grade 2–3in 12 (39%). Other toxicities were mild.
Conclusions:The combination of CPT-11 and cisplatin hasmanageable toxicity and interesting activity as salvage treatment of patientswith advanced NSCLC, previously treated with a docetaxel-based front-lineregimen. 相似文献
19.
Phase II study of docetaxel and cisplatin combination chemotherapy in metastatic or unresectable localized non-small-cell lung cancer 总被引:3,自引:0,他引:3
Kim YH Kim JS Choi YH In KH Park HS Hong DS Jeong TJ Lee YY Nam E Lee SN Lee KS Kim HK 《International journal of clinical oncology / Japan Society of Clinical Oncology》2002,7(2):114-119
Methods. Newly diagnosed, chemotherapy-naive patients with histologically confirmed NSCLC (measurable stage IIIB/IV NSCLC; Karnofsky
performance status, 70–100; adequate bone marrow, renal, hepatic, and cardiac function) were eligible for the study. Docetaxel
75 mg/m2 was administered IV over 1 h, followed immediately by cisplatin 75 mg/m2, given IV over 30 min, with cycles repeated every 3 weeks, for up to six or nine cycles.
Results. Thirty-nine patients were enrolled and treated. Their median age was 59 years (range, 32–71 years) and median performance
status, 90 (range, 70–100). Histologically, 23 patients (59%) had adenocarcinoma, 12 (30.8%) had squamous cell carcinoma,
and 16 patients (41%) had stage IV disease. Thirty-seven patients were eligible for inclusion. In the 39 patients evaluable
for safety, significant grade 3/4 toxicities included neutropenia (82%), nausea (10.3%), fatigue (10.3%), and diarrhea (7.7%).
Of the 33 patients evaluable for response, 16 patients (48.5%) achieved a partial response and 7 showed progressive disease.
Median overall survival time in all eligible patients was 10.5 months.
Conclusion. Docetaxel/cisplatin produced promising response rates that compare favorably with those of current standard platinum combinations,
with manageable toxicity. Further investigations of this first-line combination in NSCLC are warranted.
Received: September 5, 2001 / Accepted: January 28, 2002 相似文献
20.
Jung Hye Kwon Jung Han Kim Jung-Ae Lee Hyun Chun Shin Hyo Jung Kim Hun Ho Song Joo Young Jung Ho Young Kim Dae Ro Choi Hyeong Su Kim Young-iee Park Dae Young Zang 《Cancer chemotherapy and pharmacology》2010,66(5):889-897