Consolidation Docetaxel After Concurrent Chemoradiotherapy in Stage IIIB Non–Small-Cell Lung Cancer: Phase II Southwest Oncology Group Study S9504

Gandara, David R.; Chansky, Kari; Albain, Kathy S.; Leigh, Bryan R.; Gaspar, Laurie E.; Lara, Primo N.; Burris, Howard A.; Gumerlock, Paul H.; Kuebler, J. Philip; Bearden, James D.; Crowley, John; Livingston, Robert B.

doi:10.1200/jco.2003.04.197

Cited by 342 publications

(193 citation statements)

References 26 publications

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“…This study has demonstrated encouraging survival in the cooperative group setting with 37% of patients alive at 3 years (25).…”

Section: Discussionmentioning

confidence: 96%

Randomized Phase II Trial of Sequential Chemotherapy in Advanced Non-Small Cell Lung Cancer (SWOG 9806)

Edelman¹,

Clark²,

Chansky³

et al. 2004

Clinical Cancer Research

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Purpose: Improving chemotherapeutic efficacy in nonsmall cell lung cancer (NSCLC) will require the development of new drugs or new strategies to better use currently available agents. Sequential administration offers an opportunity to increase drug diversity while maintaining dose intensity. On the basis of the data indicating the activity of taxanes as second-line therapy and the lack of efficacy for more than three cycles of platinum-based therapy, this randomized Phase II study tested the concept of planned sequential chemotherapy in advanced NSCLC.Experimental Design: Patients with selected stage IIIb (pleural effusion)/stage IV NSCLC, performance status of 0 -1 and normal organ function were eligible. Therapy: arm 1, carboplatin (area under the curve ‫؍‬ 5.5 mg/ml ؋ min day 1) and gemcitabine (1000 mg/m 2 days 1 and 8 every 21 days ؋ 3) followed by paclitaxel (225 mg/m 2 every 21 days ؋ 3) or arm 2, cisplatin (100 mg/m 2 day 1), vinorelbine (25 mg/m 2 days 1 and 8 every 21 d ؋ 3) followed by docetaxel (75-100 mg/m 2 every 21 days ؋ 3). Results: Two-hundred four patients were accrued, of whom, 178 were eligible and evaluable. Eighty percent of patients were stage IV on arm 1 and 85% on arm 2. Response rates were 21 and 28% on arms 1 and 2, respectively. Median, 1-year and 2-year survivals were 9 months, 34 and 13%, and 9 months, 36 and 8%, on arms 1 and 2, respectively.Conclusions: Sequential therapy, as used in this study, resulted in comparable efficacy to previous Southwest Oncology Group trials of two drug combinations in this population; however, it failed to meet criteria for further study.

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“…This study has demonstrated encouraging survival in the cooperative group setting with 37% of patients alive at 3 years (25).…”

Section: Discussionmentioning

confidence: 96%

Randomized Phase II Trial of Sequential Chemotherapy in Advanced Non-Small Cell Lung Cancer (SWOG 9806)

Edelman¹,

Clark²,

Chansky³

et al. 2004

Clinical Cancer Research

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“…Sekine I and Nokihara H revealed that cisplatin, vinorelbine concurrent TRT before docetaxel consolidation therapy resulted in 81, 81, 10, 10% of patients associated with grade 3/4 leukopenia, neutropenia, pneumonitis, esophagitis in unresectable stage III NSCLC [25]. Gandara DR and Chansky K demonstrated that cisplatin and S-1 with concurrent TRT in unresectable stage III NSCLC patients undergone grade 3/4 leukopenia in 50%, neutropenia in 25%, pneumonitis in 26% of patients [26]. A Japanese study reported that cisplatin or carboplatin, paclitaxel and docetaxel with concurrent RT resulted in an incidence of 13% acute grade 3/4 pneumonitis toxicity and 13% grade 3/4 esophageal toxicity in stage III elderly NSCLC patients [27].…”

Section: Discussionmentioning

confidence: 99%

Concurrent chemoradiotherapy with weekly nedaplatin versus radiotherapy alone in elderly patients with non-small-cell lung cancer

Chen

Liang

et al. 2017

Clin Transl Oncol

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Purpose We conduct this study to compare the efficacy and toxicity of intensity-modulated radiotherapy (IMRT) concurrent weekly nedaplatin (NDP) versus IMRT alone in the stage III/IV non-surgical elderly patients with nonsmall-cell lung cancer (NSCLC). Methods 117 patients were enrolled into our study. The patients were assigned into two different groups: radiotherapy (RT) group and chemoradiotherapy (CRT) group. Patients in RT group were treated with IMRT at a single daily dose of 2 Gy for 5 days per week, totally 52-66 Gy. The CRT group, IMRT concurrent weekly NDP at a dose of 25 mg/m 2 . Results In CRT group, the median survival was 11.0 months (95% confidence interval [CI], 8.894-13.106 months) and in RT group, it was 7.0 months (95% CI 5.771-8.229 months). The 1-year, 2-year, 3-year, survival rates in the combined treatment arm were higher than the radiation therapy arm (46.8 vs 25.9%, 25.1 vs 11.8%, 14.7 vs 8.0%; p \ 0.001). The Cox's multiple regression analysis showed that CRT had significantly better overall survival than RT (HR 0.523; 95.0% CI 0.338-0.807; p = 0.003). The objective response rate provided that 73.3% treated with CRT compared with 51.1% (p = 0.018) received RT alone. Of the hematologic toxicities, leukocytes (35.0 vs 0%; p \ 0.001), neutrophils (33.3 vs 0%; p \ 0.001) were significantly more common in the CRT group than the RT group. Conclusions We first discovered that NDP concurrent IMRT for treating stage III/IV non-surgical elderly patients with NSCLC was good curative effect of better objective response rate and well-tolerated. However, within the low number of patients, only stage IV gained a survival benefit.

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“…The current role of consolidation chemotherapy following either high-dose palliative or radical CRT has not been established. Two phase II trials, one of which was a three-arm randomised study, have suggested an improved survival with the addition of consolidation chemotherapy to radical CRT relative to CRT alone (Choy et al, 2002;Gandara et al, 2003). Within the limits imposed by a phase I trial design, the regimen has demonstrated promising efficacy, with a overall radiological response rate (in and out of field) of 65% (15/23) comprising of CR in 4% (one) and PR in 61% (14).…”

Section: Discussionmentioning

confidence: 99%

A phase I trial of high-dose palliative radiotherapy plus concurrent weekly Vinorelbine and Cisplatin in patients with locally advanced and metastatic NSCLC

et al. 2005

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The role of concurrent chemoradiotherapy (CRT) in patients with non-small-cell lung cancer (NSCLC) unsuitable for radical therapy but who require locoregional treatment has not been defined. The aims of this phase I trial were thus to develop a novel regimen of weekly chemotherapy concurrent with high-dose palliative RT (40 Gy/20 fractions) and assess its tolerability, objective and symptomatic response rates. Eligible patients had stage I -IIIB NSCLC unsuitable for radical RT or limited stage IV disease, ECOG PSp1 and required locoregional therapy. Treatment was RT (40 Gy/20 fractions/5 per week) and weekly Vinorelbine plus Cisplatin escalated in six planned dose levels (DLs). At 4 weeks post-RT, patients received two cycles of Cisplatin 80 mg m À2 day 1 þ Vinorelbine 25 mg m À2 days 1, 8, 15. Dose-limiting toxicities (DLTs) were defined in the CRT phase. Disease-related symptoms were assessed by the Lung Cancer Symptom Scale. In all, 24 patients accrued, stage IIIB (n ¼ 12) and IV disease (n ¼ 10). The highest administered dose was at DL 4, Vinorelbine 30 mg m À2 þ Cisplatin 20 mg m À2 with DLTs of grade 4 neutropenia in two of three patients. No grade 3 or 4 nonhaematological toxicities were observed. The overall radiological response rate was 65% (n ¼ 23: complete response 4% and partial response 61%) and infield FDG-PET responses were seen in 89% (n ¼ 18). There was an improvement or stabilisation of symptoms and quality of life. Dose level 3, Vinorelbine 25 mg m À2 þ Cisplatin 20 mg m À2 , is recommended for further assessment. This regimen was tolerable and produced meaningful responses for patients for whom locoregional control is required, but who are unsuitable for radical CRT.

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Consolidation Docetaxel After Concurrent Chemoradiotherapy in Stage IIIB Non–Small-Cell Lung Cancer: Phase II Southwest Oncology Group Study S9504

Cited by 342 publications

References 26 publications

Randomized Phase II Trial of Sequential Chemotherapy in Advanced Non-Small Cell Lung Cancer (SWOG 9806)

Randomized Phase II Trial of Sequential Chemotherapy in Advanced Non-Small Cell Lung Cancer (SWOG 9806)

Concurrent chemoradiotherapy with weekly nedaplatin versus radiotherapy alone in elderly patients with non-small-cell lung cancer

A phase I trial of high-dose palliative radiotherapy plus concurrent weekly Vinorelbine and Cisplatin in patients with locally advanced and metastatic NSCLC

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