Further evidence in favour of chemotherapy for inoperable non-small cell lung cancer

Buccheri, Gianfranco; Ferrigno, Domenico; Rosso, Alberto; Vola, Ferruccio

doi:10.1016/0169-5002(90)90112-y

Cited by 32 publications

(5 citation statements)

References 23 publications

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“…Patient selection undoubtedly influences the outcome of any trial, and trials that enroll few patients are at the greatest risk of bias based on this issue. In any case, even with the cautiousness necessary in comparing different trials, a median survival of 58 week--after a first treatment failure--is, by far, longer than the 16 week survival time, measured from the time of diagnosis in nine studies of BSC [30]. As in any of the afore discussed trials [11,[27][28][29], the toxicity profile of low-dose weekly paclitaxel was favorable also in our study.…”

Section: Discussionmentioning

confidence: 43%

Second-line weekly paclitaxel in patients with inoperable non-small cell lung cancer who fail combination chemotherapy with cisplatin

Buccheri

Ferrigno

2004

Lung Cancer

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Section: Discussionmentioning

confidence: 43%

Second-line weekly paclitaxel in patients with inoperable non-small cell lung cancer who fail combination chemotherapy with cisplatin

Buccheri

Ferrigno

2004

Lung Cancer

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“…This figure is remarkably recurrent in studies that tested single‐agent vinorelbine in the elderly,11, 13 as well as in studies that focused on younger populations 17, 34. It compares favorably with most standard platinum‐based combinations,17, 35 including all the regimens that were compared with the best supportive care 36. Finally, although one must be cautious in comparing different trials, a median survival of 34 week is, by far, longer than the 16 week survival reported, on average, in the 9 control arms of best supportive care 36.…”

Section: Discussionmentioning

confidence: 96%

“…It compares favorably with most standard platinum‐based combinations,17, 35 including all the regimens that were compared with the best supportive care 36. Finally, although one must be cautious in comparing different trials, a median survival of 34 week is, by far, longer than the 16 week survival reported, on average, in the 9 control arms of best supportive care 36. This study therefore lends further support to the conclusion of the ELVIS trial, that suggests a survival benefit from chemotherapy also in the elderly 13.…”

Section: Discussionmentioning

confidence: 99%

Vinorelbine in elderly patients with inoperable nonsmall cell lung carcinoma

Buccheri¹,

Ferrigno²

2000

Cancer

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BACKGROUND Cancer in the elderly is becoming a complex and frequent issue. At least 30% of lung carcinomas are expected to arise each year in elderly patients, who often have significant comorbidity. The most appropriate treatment for this large portion of cancer patients remains unknown. The purpose of this Phase II trial was to make a comprehensive evaluation of the activity, toxicity, and tolerability of single‐agent vinorelbine in elderly and relatively poorly performing patients with inoperable nonsmall cell lung carcinoma (NSCLC). METHODS Patients age 70 years or older were eligible to participate in this trial if they had a pathologic diagnosis, a performance status lower than 4 (Eastern Cooperative Oncology Group [ECOG] scale), and gave informed consent. Vinorelbine was given intravenously (i.v.) at a dose of 25 mg/m2 every week until progression, persistent toxicity, or refusal. RESULTS Forty‐six patients entered the study; their median age was 75 years (range, 70–83 years). Five patients never started on vinorelbine; 27 others had early treatment suspensions. The median number of weekly infusions was 5 (range, 0–28); the median dose intensity was 70% of projected. Toxicity was generally mild, mainly hematologic, and never life‐threatening. ECOG performance status, body weight, and almost all the scores from the quality‐of‐life questionnaires remained constant during the first 6 weeks of treatment. Two patients obtained partial response, 10 patients had some tumor regression, and 26 had tumor stabilization. The estimated median time to progression was 19 weeks (quartile range, 11–23 weeks), and the median survival 34 weeks (quartile range, 16–63 weeks). CONCLUSIONS In our group of patients who had poor prognoses, vinorelbine was well tolerated, moderately active, and capable of ensuring relatively long survival. It may represent a valuable therapeutic option for the treatment of nonresectable NSCLC in elderly patients. Cancer 2000;88:2677–85. © 2000 American Cancer Society.

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“…We used data both from a set of 323 NSCLC patients undergoing tumor resection with curative intent at our institution as well as using OS and PFS curves from arbitrarily selected NSCLC trials published from 1986 to 2006 involving front-line chemotherapy in advanced disease3-20, adjuvant chemotherapy in resected stage I-III disease6, 21-31 and survival as a function of stage4, 6, 14, 20-24, 26-38, and also used curves from best supportive care arms from 2 second line therapy trials39, 40. For this preliminary feasibility assessment, the only criteria used to select studies were that they dealt with NSCLC and that they had published OS or PFS curves related to therapy or stage that were sufficiently legible to permit us to perform the planned manual measurements.…”

Section: Methodsmentioning

confidence: 99%

Exponential decay nonlinear regression analysis of patient survival curves: Preliminary assessment in non-small cell lung cancer

2011

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Background For processes that follow first order kinetics, exponential decay nonlinear regression analysis (EDNRA) may delineate curve characteristics and suggest processes affecting curve shape. We conducted a preliminary feasibility assessment of EDNRA of patient survival curves. Methods EDNRA was performed on Kaplan-Meier overall survival (OS) and time-to-relapse (TTR) curves for 323 patients with resected NSCLC and on OS and progression-free survival (PFS) curves from selected publications. Results and Conclusions In our resected patients, TTR curves were triphasic with a “cured” fraction of 60.7% (half-life [t1/2] >100,000 months), a rapidly-relapsing group (7.4%, t1/2=5.9 months) and a slowly-relapsing group (31.9%, t1/2=23.6 months). OS was uniphasic (t1/2=74.3 months), suggesting an impact of co-morbidities; hence, tumor molecular characteristics would more likely predict TTR than OS. Of 172 published curves analyzed, 72 (42%) were uniphasic, 92 (53%) were biphasic, 8 (5%) were triphasic. With first-line chemotherapy in advanced NSCLC, 87.5% of curves from 2-3 drug regimens were uniphasic vs only 20% of those with best supportive care or 1 drug (p<0.001). 54% of curves from 2-3 drug regimens had convex rapid-decay phases vs 0% with fewer agents (p<0.001). Curve convexities suggest that discontinuing chemotherapy after 3-6 cycles “synchronizes” patient progression and death. With postoperative adjuvant chemotherapy, the PFS rapid-decay phase accounted for a smaller proportion of the population than in controls (p=0.02) with no significant difference in rapid-decay t1/2, suggesting adjuvant chemotherapy may move a subpopulation of patients with sensitive tumors from the relapsing group to the cured group, with minimal impact on time to relapse for a larger group of patients with resistant tumors. In untreated patients, the proportion of patients in the rapid-decay phase increased (p=0.04) while rapid-decay t1/2 decreased (p=0.0004) with increasing stage, suggesting that higher stage may be associated with tumor cells that both grow more rapidly and have a higher probability of surviving metastatic processes than in early stage tumors. This preliminary assessment of EDNRA suggests that it may be worth exploring this approach further using more sophisticated, statistically rigorous nonlinear modelling approaches. Using such approaches to supplement standard survival analyses could suggest or support specific testable hypotheses.

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Further evidence in favour of chemotherapy for inoperable non-small cell lung cancer

Cited by 32 publications

References 23 publications

Second-line weekly paclitaxel in patients with inoperable non-small cell lung cancer who fail combination chemotherapy with cisplatin

Second-line weekly paclitaxel in patients with inoperable non-small cell lung cancer who fail combination chemotherapy with cisplatin

Vinorelbine in elderly patients with inoperable nonsmall cell lung carcinoma

Exponential decay nonlinear regression analysis of patient survival curves: Preliminary assessment in non-small cell lung cancer

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