Ifosfamide, Carboplatin, and Etoposide With Midcycle Vincristine Versus Standard Chemotherapy in Patients With Small-Cell Lung Cancer and Good Performance Status: Clinical and Quality-of-Life Results of the British Medical Research Council Multicenter Randomized LU21 Trial

2005 ◽  
Vol 23 (33) ◽  
pp. 8371-8379 ◽  
Author(s):  
Nicholas Thatcher ◽  
Wendi Qian ◽  
Peter I. Clark ◽  
Penelope Hopwood ◽  
Robert J. Sambrook ◽  
...  

Purpose Ifosfamide, carboplatin, etoposide, and vincristine, alone and in combination, are highly active against small-cell lung cancer (SCLC). This trial was designed to investigate whether survival could be improved by a regimen of all four drugs (ICE-V) compared with standard chemotherapy in patients with SCLC and good performance status, and to assess the patients’ quality of life (QL). Patients and Methods Patients were randomly assigned to receive six cycles of either ICE-V at 4-week intervals without dose reduction or standard chemotherapy administered according to local practice. The recommended standard control regimens were cyclophosphamide, doxorubicin, and etoposide; and cisplatin and etoposide. Results A total of 402 patients were randomly assigned, and 350 (87%) patients have died. Overall survival was longer in the ICE-V group (hazard ratio, 0.74; 95% CI, 0.60 to 0.91; P = .0049), median survival was 15.6 months in the ICE-V group and 11.6 months in the control group, and 2-year survival rates were 20% and 11%, respectively. There was no evidence that the relative survival benefit for ICE-V was less in extensive-stage than in limited-stage patients. An increased rate of septicemia was reported in the ICE-V group (15% v 7% in the control group), but this did not result in an increase in reported treatment-related deaths (four patients [2%] in both groups). The findings on QL were broadly similar in both groups, with some benefit in favor of ICE-V. Conclusion Compared with standard chemotherapy, the ICE-V regimen improves overall survival without QL penalties, despite an increased but manageable level of toxicity.

2009 ◽  
Vol 4 (9) ◽  
pp. 1075-1082 ◽  
Author(s):  
Yingwei Qi ◽  
Steven E. Schild ◽  
Sumithra J. Mandrekar ◽  
Angelina D. Tan ◽  
James E. Krook ◽  
...  

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7515-7515 ◽  
Author(s):  
Nobuyuki Katakami ◽  
Akihiko Gemma ◽  
Hiroshi Sakai ◽  
Kaoru Kubota ◽  
Makoto Nishio ◽  
...  

7515 Background: Although molecularly targeted therapy improves outcome of selected patients with advanced non-small-cell lung cancer (NSCLC), most of the patients ultimately become candidates of cytotoxic chemotherapy, which is the cornerstone of patient management. S-1 plus cisplatin (SP) has shown activity and good tolerability in phase II settings. Docetaxel plus cisplatin (DP) is the only third-generation regimen that demonstrated statistically significant improvement of overall survival and quality of life by head to head comparison with a second-generation regimen, vindesine plus cisplatin, in patients with advanced NSCLC. Methods: Patients with previously untreated stage IIIB or IV NSCLC, an ECOG PS of 0-1 and adequate organ functions were randomized to receive either oral S-1 80 mg/m2/day (40 mg/m2 b.i.d.) on days 1 to 21 plus cisplatin 60 mg/m2 on day 8 every 5 weeks or docetaxel 60mg/m2 on day 1 plus cisplatin 80 mg/m2 on day 1 every 3 weeks, both up to 6 cycles. The primary endpoint is overall survival (OS). Non-inferiority study design was employed as upper confidence interval (CI) limit for HR<1.322. Secondary endpoints include progression-free survival (PFS), response, safety, and quality of life (QOL). Results: From April 2007 to December 2008, 608 patients from 66 sites in Japan were randomized to SP (n=303) or DP (n=305). Patient demographics were well balanced between the two groups. Two interim analyses were preplanned. At the final analysis, total of 480 death events were observed. The primary endpoint was met. OS for SP was non inferior to DP (median survival, 16.1 v 17.1 months, respectively; HR=1.013; 96.4% CI, 0.837-1.227). PFS was 4.9 months in the SP arm and 5.2 months in the DP arm. Statistically significantly lower rate of febrile neutropenia (7.4% v 1.0%), grade 3/4 neutropenia (73.4% v 22.9%), grade 3/4 infection (14.5% v 5.3%), grade 1/2 alopecia (59.3% v 12.3%) were observed in the SP arm than in the DP arm. QOL data investigated by EORTC QLQ-C30 and LC-13 favored for the SP arm. Conclusions: S-1 plus cisplatin is a standard first-line chemotherapy regimen for advanced NSCLC.


2007 ◽  
Vol 2 (12) ◽  
pp. 1091-1097 ◽  
Author(s):  
Tawee Tanvetyanon ◽  
Heloisa P. Soares ◽  
Benjamin Djulbegovic ◽  
Paul B. Jacobsen ◽  
Gerold Bepler

2005 ◽  
Vol 23 (13) ◽  
pp. 2946-2954 ◽  
Author(s):  
David Cella ◽  
Roy S. Herbst ◽  
Thomas J. Lynch ◽  
Diane Prager ◽  
Chandra P. Belani ◽  
...  

Purpose Evaluation of disease-related symptom improvement rate by the Lung Cancer Subscale (LCS) of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire was a coprimary end point of the pivotal phase II trial of gefitinib (Iressa; AstraZeneca, Wilmington, DE) conducted in the United States. This report includes the results of analyses exploring the relationship between weekly LCS scores and radiographic response and survival, as well as detailed protocol-specified analysis of symptom and quality-of-life data. Patients and Methods In this trial, 216 symptomatic patients with advanced non-small-cell lung cancer (NSCLC) who had at least two prior chemotherapy regimens received gefitinib 250 or 500 mg/d. Disease-related symptoms were assessed weekly and quality of life was assessed monthly by LCS and FACT-L, respectively. Results Symptom improvement was rapid and correlated with tumor response and survival. At the recommended gefitinib dose of 250 mg/d, median overall survival times were 13.6 and 4.6 months for patients with and without symptom improvement, respectively, and 9.7 months for patients with symptom improvement without tumor response. Among patients with stable disease or disease progression, those with symptom improvement had significantly better overall survival than those without improvement. At 250 mg/d, 30% of patients showed a quality-of-life improvement that was correlated with tumor response. Conclusion This triadic analysis of response, survival, and symptom data supports the hypothesis that tumor response and symptom response are related and that each predicts survival. Among these NSCLC patients treated with gefitinib, symptom improvement was complementary to and, for most patients, preceded evidence of radiographic regression.


2003 ◽  
Vol 11 (3) ◽  
pp. 196-196
Author(s):  
Suzana Isakovic-Vidovic ◽  
Nenad Borojevic ◽  
Ljiljana Radosevic-Jelic ◽  
Tatjana Pekmezovic

Background: The aim was to investigate the application of radiopotentiation which was initiated by the fact that in patients with locally advanced non-small cell lung cancer there is a high risk of relapse due to failure in local control of the disease and the risk of systemic micrometastases. The other aim was the evaluation of quality of life. Methods: A study group consisted of 67 patients. Patients were first treated with TD30 Gy in 10 fractions during 2 weeks (5 fractions per week) with a potentiation by 20 mg/m 2 of carboplatinol intravenous bolus infusion just prior to each radiotherapy fraction. After a 2-week pause, additional radiation of 25 Gy in 10 fractions was applied during 2 weeks (5 fractions/week) with a potentiation by 20 mg/m 2 of carboplatinol. Total tumor dose (TTD) was 55 Gy (30+25 Gy) in 20 fractions, total duration of the therapy was 6 weeks, and total dose of carboplatinol was 600 mg. A control group consisted of 70 patients and they were treated with a radical radiotherapy with a conventional fractionation (60 Gy in 30 fractions, 2 Gy per day, 5 fractions per week). Quality of life was evaluated by Karnofsky performance scale (KI), at the beginning of the treatment, after the completion of the whole course of treatment, and during follow-up at regular check-ups. Results After the completion of the whole course of treatment most of patients had KI 80%. Analysis made during the last check-up showed statistically significant low KI. In both study and control groups KI was significantly higher at the beginning of the treatment than KI after the completion of the whole course of treatment (p=0.001). However, the analysis of KI at the time of the completion of the whole course of treatment showed significantly better KI in study group (p=0.036) than in control group. Conclusion: These results showed that the combined radiochemotherapy treatment is well tolerated.


2021 ◽  
Vol 37 (4) ◽  
Author(s):  
Yu-jie Cui ◽  
Jia Liu ◽  
Miao-miao Liu ◽  
Hong-zhen Zhang

Objectives: To evaluate the clinical effect of apatinib combined with chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC). Methods: Eighty patients with advanced NSCLC treated in Hebei General Hospital from January 2017 to July 2020 were randomly divided into two groups: the experimental group and the control group, each with 40 cases. Patients in the control group were treated with conventional paclitaxel combined with cisplatin chemotherapy, while patients in the experimental group were treated with apatinib mesylate tablets based on the treatment of the control group. After treatment, tumor efficacy evaluation was conducted on all patients every two cycles, and the therapeutic effect, adverse drug reactions, improvement of quality-of-life scores prior to and after treatment, and changes of indicators such as tumor markers carcinoembryonic antigen (CEA) and carbohydrate antigen 153(CA153) were compared and analyzed between the two groups.  Results: The total effective rate of the experimental group was 67.5%, which was significantly better than the 45% of the control group (p=0.04); The incidence of adverse drug reactions in the experimental group was 25%, while that in the control group was 37.5%, with no significant difference (p=0.23); Moreover, the improvement rate of quality of life scores in the experimental group was significantly higher than that in the control group (p=0.03), and the levels of CEA and CA153 in the experimental group were significantly lower after treatment than those in the control group, with a statistically significant difference (p=0.01). Conclusion: Apatinib combined with conventional chemotherapy is effective in the treatment of advanced non-small cell lung cancer, the quality of life can be significantly improved, tumor markers can be significantly reduced, and adverse reactions will not be significantly increased. doi: https://doi.org/10.12669/pjms.37.4.4066 How to cite this:Cui Y, Liu J, Liu M, Zhang H. Observation on the Clinical Effect of Apatinib Combined with Chemotherapy in the Treatment of Advanced Non-Small Cell Lung Cancer. Pak J Med Sci. 2021;37(4):---------.   doi: https://doi.org/10.12669/pjms.37.4.4066 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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