Topotecan/Cisplatin Compared with Cisplatin/Etoposide as First-Line Treatment for Patients with Extensive Disease Small-Cell Lung Cancer: Final Results of a Randomized Phase III Trial

Fink, T.; Huber, Rudolf M.; Heigener, David F.; Eschbach, C.; Waller, Christiane; Steinhauer, E. U.; Virchow, J. Christian; Eberhardt, Frank; Schweisfurth, H.; Schroêder, M.; Ittel, T. H.; Hummler, Simone; Banik, Norbert; Bogenrieder, Thomas; Acker, Thomas; Wolf, M.

doi:10.1097/jto.0b013e318260de75

Cited by 43 publications

(33 citation statements)

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“…Life expectancy was shortened by .10 years among the current smokers compared with those who had never smoked. Adults who had quit smoking [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44] or 45-54 years of age gained approximately 10, 9 and 6 years of life, respectively, compared with those who continued to smoke. This is in complete agreement with the UK observation.…”

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confidence: 99%

Updates in oncology

Sculier¹,

Meert²,

Berghmans³

2014

European Respiratory Review

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The objective of this review is to report the Clinical Year in Review proceedings in the field of thoracic oncology that were presented at the 2013 European Respiratory Society Annual Congress in Barcelona, Spain. Various topics were reviewed, including: epidemiology, screening, histology, and treatment of nonsmall cell lung cancer and small cell lung cancer. @ERSpublications Lung cancer increasing in females; screening based on risk selection; doublet platinum-based chemotherapy recommended http://ow.ly/sjbR6 EpidemiologyEuropean cancer mortality predictions for lung cancer in 2013 report a continuing reduction in males, but a continuing increase in females [1]. For the first time in females, mortality from lung and breast cancers should be equivalent. In 2013, age-standardised mortality rates per 100 000 are estimated to be 37.1 in males and 13.9 in females for lung cancer.A US epidemiological study [2] has confirmed the data of the UK doctors' cohort [3]. The authors obtained smoking and smoking-cessation histories from 113 752 females and 88 496 males who were interviewed between 1997 and 2004. These data were related to the causes of deaths that occurred by the end of 2006 (8236 deaths in females and 7479 in males). The rate of death from any cause among current smokers was approximately three times that among those who had never smoked. The hazard ratios for females and males were 3.0 (99% CI 2.7-3.3) and 2.8 (99% CI 2.4-3.1), respectively. Life expectancy was shortened by .10 years among the current smokers compared with those who had never smoked. Adults who had quit smoking 25-34, 35-44 or 45-54 years of age gained approximately 10, 9 and 6 years of life, respectively, compared with those who continued to smoke. This is in complete agreement with the UK observation.Temporal trends in mortality across three time-periods (1959-1965, 1982-1988 and 2000-2010) were compared in terms of absolute and relative risks according to sex and self-reported smoking status in two historical and five pooled contemporary US cohort studies [4]. For females who were current smokers compared with females who had never smoked, the relative risk of death from lung cancer was 2. 73, 12.65 and 25.66 in the 1960s, 1980s and contemporary cohorts, respectively; corresponding relative risk for male current smokers compared with males who had never smoked was 12.22, 23.81 and 24.97 over the same time-periods, respectively. As in Europe, the risk of death by lung cancer from cigarette smoking in the USA continues to increase among females and the increased risks are now nearly identical for males and females; however, this is not the case in Europe.By pooled analysis, the International Lung Cancer Consortium determined the associations between prior lung diseases and the occurrence of lung cancer [5]. The analysis included 17 studies with 24 607 cases and

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confidence: 99%

Updates in oncology

Sculier¹,

Meert²,

Berghmans³

2014

European Respiratory Review

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“…However, even those with an increase in tumour size after the first course had a median overall survival of 19.9 months, which is much longer than in extended disease (typically 8-12 months) [27,28]. It is, however, possible that an early response assessment as described herein might be used for randomisation or stratification in future studies.…”

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confidence: 99%

Tumour size reduction after the first chemotherapy-course and outcomes of chemoradiotherapy in limited disease small-cell lung cancer

et al. 2016

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Prognostic value of tumour size reduction after the first chemotherapy-course in LD SCLC 2 Abstract ObjectivesConcurrent chemotherapy and thoracic radiotherapy (TRT) is recommended for limited disease smallcell lung cancer (LD SCLC). TRT should start as early as possible, often meaning with the second course due to patient referral time and the fact that TRT planning takes time. Early assessment of response to the first course of chemotherapy may be a useful way to individualise treatment. The aims of this study were to assess tumour size reduction after the first chemotherapy-course, and whether this reduction was associated with outcomes in LD SCLC. Material and methodsA randomised trial comparing twice-daily (45Gy/30 fractions) with once-daily (42 Gy/15 fractions) TRT, given concurrently with four courses of cisplatin/etoposide (n=157) was the basis for this study.Tumour size was assessed on CT scans at baseline and planning scans for TRT according to RECIST 1.0. Results CT scans were available for 135 patients (86%). Ninety-four percent had a reduction in tumour sizeafter the first chemotherapy-course. The median reduction in sum of diameters (SOD) of measurable lesions was ÷16 mm (÷84 to +10 mm), corresponding to ÷18% (÷51 to +12%). Eighty-two percent had stable disease, 18% partial response. Reduction in SOD was significantly associated with complete response at first follow-up (OR: 1.05, 95% CI 1.01-1.09; p=.013), PFS (HR: 0.97, 95% CI 0.96-0.99; p=.001), and overall survival (HR: 0.98, 95% CI 0.96-1.00; p=.010). ConclusionResponse from the first course of chemotherapy had a significant positive association with outcomes from chemoradiotherapy, and might be used to stratify and randomise patients in future studies.Prognostic value of tumour size reduction after the first chemotherapy-course in LD SCLC 3

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“…The OS of patients with ED-SCLC enrolled in phase III trials has not improved significantly over the last few years (17). Recent phase III trials investigating ED-SCLC (3,10,11,(18)(19)(20) revealed a median OS of ~9-11 months, regardless of the treatment options. Lara et al (11) reported a pivotal trial including 651 patients comparing the efficacy of EP and IP as first-line treatment for patients with ED-SCLC.…”

Section: Discussionmentioning

confidence: 99%

“…A total of 327 patients were assigned to the EP arm, exhibiting a median PFS of 5.2 months and a median OS of 9.1 months. Fink et al (18) evaluated the efficacy of EP and topotecan/cisplatin as first-line treatment for patients with ED-SCLC. The EP arm included 345 patients with a median time-to-progression of 5.7 months and a median OS of 9.5 months.…”

Section: Discussionmentioning

confidence: 99%

“…In the phase III study of Fink et al (18), 37.7 and 2.7% of the 334 EP-treated patients developed grade 4 neutropenia and febrile neutropenia, respectively. Lara et al (11) reported that grade 4 neutropenia and febrile neutropenia occurred in 48 and 6%, respectively, of 324 patients who were treated with EP.…”

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confidence: 99%

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Modified one-day etoposide and cisplatin combination for previously untreated extensive-disease small-cell lung cancer: A retrospective evaluation of 36 cases

Cho

Kim

Jang

et al. 2015

Molecular and Clinical Oncology

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Abstract. The combination of etoposide and cisplatin (EP) remains one of the standard first-line treatments for extensive-disease small-cell lung cancer (ED-SCLC) We devised a one-day modified EP regimen for better tolerance and convenience by modifying the dose and schedule of conventional EP with administration over 3-5 consecutive days. The modified EP consists of two infusions of etoposide (120 mg/m 2 each) and 60 mg/m 2 of cisplatin on day 1 of a 21-day cycle and a maximum of 6 cycles of treatment. A total of 36 consecutive ED-SCLC patients were treated with the modified EP as first-line therapy and retrospectively reviewed to assess the efficacy and safety of this regimen. Of the 36 patients, 24 exhibited confirmed objective tumor response (overall response rate of 66%, with a complete response rate of 3% and a partial response rate of 63%). The median overall survival (OS) was 11.8 months [95% confidence interval (CI): 7.9-15.3] and the progression-free survival (PFS) was 7.3 months (95% CI: 5.2-9.7). The survival estimates at 1 year were 35 and 17% for OS and PFS, respectively. The chemotherapy treatment was well tolerated, with only one case of grade 4 non-hematological adverse events, no grade 4 hematological toxicities and no treatment-related deaths. The mean relative dose intensity of etoposide and cisplatin was measured to be 94.7 and 98.5% of the planned dose, respectively. Therefore, the modified EP warrants further clinical research regarding its effectiveness, toxicity profile and convenience of administration. Prospective randomized clinical trials are required to determine the therapeutic role of the modified EP as first-line treatment in patients with ED-SCLC.

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Topotecan/Cisplatin Compared with Cisplatin/Etoposide as First-Line Treatment for Patients with Extensive Disease Small-Cell Lung Cancer: Final Results of a Randomized Phase III Trial

Abstract: TP is noninferior to PE in overall survival and superior in time to progression and overall response rates. Because of slightly worse toxicity profile TP is not a first-line standard treatment for patients with extensive disease small-cell lung cancer.

Cited by 43 publications

References 13 publications

Updates in oncology

Updates in oncology

Tumour size reduction after the first chemotherapy-course and outcomes of chemoradiotherapy in limited disease small-cell lung cancer

Modified one-day etoposide and cisplatin combination for previously untreated extensive-disease small-cell lung cancer: A retrospective evaluation of 36 cases

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