Randomized Phase II Study of Cisplatin With Gemcitabine or Paclitaxel or Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemoradiotherapy for Stage IIIB Non–Small-Cell Lung Cancer: Cancer and Leukemia Group B Study 9431

Vokes, Everett E.; Herndon, James E.; Crawford, Jeffrey; Leopold, Kenneth A.; Perry, Michael C.; Miller, Antonius A.; Green, Mark R.

doi:10.1200/jco.2002.03.054

Cited by 351 publications

(245 citation statements)

References 26 publications

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“…We report that the daily cisplatin and radiotherapy arm yielded the best survival rate, supporting the idea that improving chest disease control will improve survival. In recent years, many other chemotherapeutic agents have been delivered as sensitizing agents to improve radiation effect, including the taxanes, gemcitabine, vinorelbine, and topoisomerase (17,18). Among these, paclitaxel has been a favored drug due to its ability to arrest cells at the G2/M interphase in the cell cycle.…”

Section: Discussionmentioning

confidence: 99%

Toxicity Profile and Pharmacokinetic Study of A Phase I Low-Dose Schedule–Dependent Radiosensitizing Paclitaxel Chemoradiation Regimen for Inoperable Non–Small-Cell Lung Cancer

Chen

Pandya

Feins

et al. 2008

International Journal of Radiation Oncology*Biology*Physics

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Purpose-We report the toxicity profile and pharmacokinetic data of a schedule-dependent chemoradiation regimen using pulsed low-dose paclitaxel for radiosensitization in a phase I study for inoperable non-small cell lung cancer (NSCLC).Methods and Materials-Paclitaxel at escalating doses of 15 mg/m 2 , 20 mg/m 2 , and 25 mg/m 2 were infused on Monday, Wednesday, and Friday with daily chest radiation in cohorts of 6 patients. Daily radiation (RT) was delayed for maximal G2/M arrest and apoptotic effect, an observation from preclinical investigations. Plasma paclitaxel concentration was determined by High Performance Liquid Chromatography (HPLC).Results-Dose-limiting toxicities included 3/18 patients with grade 3 pneumonitis and 3/18 patients with grade 3 esophagitis. There was no grade 4 or 5 pneumonitis or esophagitis. There was no grade 3 or 4 neutropenia, thrombocytopenia, anemia or neuropathy. For dose levels I (15 mg/m 2 ), II (20 mg/m 2 ), and III (25 mg/m 2 ), the mean peak plasma level was 0.23 ±0.06 μM, 0.32±0.05 μM, and 0.52±0.14 μM, respectively; AUC was 0.44± 0.09 μM, 0.61± 0.1 μM, and 0.96± 0.23 μM, respectively; and duration of drug concentration above 0.05 μM (t >0.05 μM) was 1.6± 0.3 hr, 1.9± 0.2 hr, and 3.0± 0.9 hr, respectively. Conclusion-Pulsed low-dose paclitaxel chemoradiation is associated with low toxicity. Pharmacokinetic data showed that plasma paclitaxel concentration above 0.05 μM for a minimum of 1.6 hours was sufficient for effective radiosensitization.

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Section: Discussionmentioning

confidence: 99%

Toxicity Profile and Pharmacokinetic Study of A Phase I Low-Dose Schedule–Dependent Radiosensitizing Paclitaxel Chemoradiation Regimen for Inoperable Non–Small-Cell Lung Cancer

Chen

Pandya

Feins

et al. 2008

International Journal of Radiation Oncology*Biology*Physics

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“…Platinum-based chemotherapy is the standard for the treatment of young, well-performing patients with metastatic NSCLC [6; 20] and most authors regard the doublet cisplatin (or carboplatin)/paclitaxel as a standard chemotherapy regimen [21][22][23][24]. In chemo-naïve patients, singleagent-paclitaxel has been studied on different The most common toxicity was alopecia (51% in all), neuropathy (never severe), anemia, and leukopenia (never associated with life-threatening infections).…”

Section: Discussionmentioning

confidence: 99%

Weekly chemotherapy with cisplatin and paclitaxel in advanced NSCLC: a phase II study

Buccheri

Ferrigno

Giordano

2016

Monaldi Arch Chest Dis

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Background. This phase II study was designed to assess the activity and toxicity of administration of the cisplatin/ paclitaxel combination in advanced non-small cell lung cancer (NSCLC). Methods. Eligibility criteria included: age up to 70 years, pathological diagnosis of NSCLC, inoperable disease or post-operative tumour recurrence, performance status </=2, no severe co-morbidity, no previous chemotherapy, and informed consent. Treatment consisted of intravenous infusion of cisplatin, 25 mg/m2, and paclitaxel, 80 mg/m2, every week. Chemotherapy was continued until completion of a 22-week treatment plan, disease progression, persistent toxicity, or patient refusal. Results. Forty-nine patients entered the study. They received a median of 14 cycles (range 0-22). For both drugs, the median dose-intensity was 75% of projected. Toxicity was generally acceptable, and never life threatening. Alopecia was the most common side effect, followed by anemia, leukopenia, and nausea/vomiting. Twenty patients responded (40.8% response rate), with three complete, pathologically documented responses. The estimated median time to progression was 35 weeks (95% CI: 29-41); the median survival time was 56 weeks (95% CI: not calculable), with a 2-year survival rate of 46.1%. Conclusions. When given on a weekly basis, the cisplatin/ paclitaxel combination is well tolerated, active, and associated to remarkably long survivals.

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“…Therefore, it is also crucial to select an appropriate chemotherapeutic regimen. CALGB9431 (22) analyzed the superiority by combining cisplatin with paclitaxel, gemcitabine and NVB, respectively, in concomitant radiochemotherapy. By comparing results, it was found that there was significantly less associated toxicity with NVB than with paclitaxel or gemcitabine with Grade III/IV neutropenia (27, 53 and 51%, respectively), and notably fewer cases of vomiting and anorexia (16, 15, 8% and 22, 27, 12%, respectively).…”

Section: Discussionmentioning

confidence: 99%

High-dose 3-dimensional conformal radiotherapy with concomitant vinorelbine plus carboplatin in patients with non-small cell lung cancer: A feasibility study

et al. 2011

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Abstract. The aim of this study was to evaluate the feasibility of high-dose 3-dimensional conformal radiotherapy (3DCRT) (70 Gy) with concomitant vinorelbine (NVB) plus carboplatin (CBP) chemotherapy in patients with non-small cell lung cancer (NSCLC). Patients with advanced NSCLC were treated with 3-dimensional conformal radiotherapy in conventional fractionation: 2 Gy/fraction, 1 fraction/day, 5 fractions/ week; total dose 70 Gy. The radiotherapy planning of every case had met the following conditions: the percentage of total lung volume receiving 20 Gy (V20) ≤30% and the percentage of total lung volume receiving 30 Gy (V30) ≤20%. Chemotherapy was commenced on the first day of radiotherapy: NVB 25 mg/m 2 , day 1 and day 8, CBP at AUC of 5 mg/ml -1 .min -1 , day 8, repeated for 28 days, two concomitant cycles during radiotherapy, and not more than 4 cycles following radiotherapy. A total of 37 patients were recruited and each of them completed the entire radiation procedure. No Grade V toxicity was observed within the group. The hematological toxicity rates were: Grade III/IV neutropenia was observed in 18.9% (7/37) of cases, Grade III/IV thrombocytopenia in 8.1% (3/37) of cases, but no cases of Grade III/IV anemia were noted. For non-hematological toxicities the rates were: Grade III radiation pneumonitis, 8.1% (3/37) of cases; Grade III radiation esophagitis, 13.5% (5/37); but no cases of Grade IV/V non-hematological toxicities. High-dose 3DCRT also achieved a favorable efficacy: the complete response (CR) rate was 13.5% (5/37) and the partial response (PR) rate was 64.9% (24/37). The total response (CR+PR) rate was 78.4% (29/37). The median survival time was 12 months and the 1-year overall survival rate was 45.1%. Given that 35% of patients in the study had stage IV disease, the survival results were comparable with other similar studies. In conclusion, in our small-sample exploratory study, the high-dose regimen of 70 Gy using 3DCRT with concomitant NVB plus CBP was feasible for patients with NSCLC. Further evaluation of this regimen is ongoing in a prospective controlled phase II trial. IntroductionLung cancer has the highest incidence and mortality rate of all malignancies. Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancers, the majority of which are at an advanced stage and unresectable when diagnosed (1). As the main approach for NSCLC, radiotherapy was adopted exclusively until the 1990s when the advantage of radiotherapy combined with chemotherapy was established by CALGB8433 (2). In addition, Furuse et al concluded the superiority of the concomitant combination over the sequencing one (3), a theory that was supported by a recent meta-analysis (4). Nine to eleven months of the median survival time (MST) for patients with advanced NSCLC treated by radiotherapy alone has been improved to approximately 16 months for those treated with radiotherapy combined with chemotherapy (2-4). A total of 60 Gy was considered to be the standard dose in conventional fractionation ra...

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Randomized Phase II Study of Cisplatin With Gemcitabine or Paclitaxel or Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemoradiotherapy for Stage IIIB Non–Small-Cell Lung Cancer: Cancer and Leukemia Group B Study 9431

Cited by 351 publications

References 26 publications

Toxicity Profile and Pharmacokinetic Study of A Phase I Low-Dose Schedule–Dependent Radiosensitizing Paclitaxel Chemoradiation Regimen for Inoperable Non–Small-Cell Lung Cancer

Toxicity Profile and Pharmacokinetic Study of A Phase I Low-Dose Schedule–Dependent Radiosensitizing Paclitaxel Chemoradiation Regimen for Inoperable Non–Small-Cell Lung Cancer

Weekly chemotherapy with cisplatin and paclitaxel in advanced NSCLC: a phase II study

High-dose 3-dimensional conformal radiotherapy with concomitant vinorelbine plus carboplatin in patients with non-small cell lung cancer: A feasibility study

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