Thoracic Radiation Therapy Alone Compared with Combined Chemoradiotherapy for Locally Unresectable Non-Small Cell Lung Cancer

Morton, Roscoe F.; Jett, James R.; McGinnis, William L.; Earle, John D.; Therneau, Terry M.; Krook, James E.; Elliott, Thomas E.; Mailliard, James A.; Nelimark, Robert A.; Maksymiuk, Andrew W.; Drummond, Ronald G.; Laurie, John A.; Kugler, John W.; Anderson, Richard

doi:10.7326/0003-4819-115-9-681

Cited by 176 publications

(31 citation statements)

References 16 publications

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“…Combination chemoradiation therapy has improved survival in patients with stage III inoperable non-small cell lung cancer when compared with radiation treatment alone (1)(2)(3)(4)(5)(6)(7)(8)(9). Despite the promising improvement by combined modality therapy, investigations using various chemoradiotherapy combinations have yielded an average 5-year survival of less than 25%.…”

Section: Introductionmentioning

confidence: 99%

“…Despite the promising improvement by combined modality therapy, investigations using various chemoradiotherapy combinations have yielded an average 5-year survival of less than 25%. While chemotherapy combinations have reached the plateau for non-small cell lung cancer (10), intrathoracic disease control is even more disappointing with an average low rate of control at 40-50% at best by radiographic criteria (1,4,6), and only 15%-17% control rate by tumor biopsy through post-treatment bronchoscopy (4). Because locoregional failure can serve as a continuous source of distant metastasis, improving chest disease control is critical in the management of locally advanced NSCLC.…”

Section: Introductionmentioning

confidence: 99%

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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: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

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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“…The efficacy of combined-modality therapy for inoperable stage III NSCLC is reported to vary and the reason for this is unclear, although differences between the eligibility criteria used in various studies may account for the different outcomes (Mattson et al, 1988;Morton et al, 1991;Sause et al, 1995). In the present study, the maximum tolerated dose of irinotecan was 60 mg m 72 .…”

Section: Clinicalmentioning

confidence: 75%

Dose-escalation study of weekly irinotecan and daily carboplatin with concurrent thoracic radiotherapy for unresectable stage III non-small cell lung cancer

et al. 2002

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Dose-escalation study was performed to evaluate the maximum tolerated dose, recommended dose and toxicity profile of weekly irinotecan with daily carboplatin and concurrent thoracic radiotherapy in patients with locally advanced non-small-cell lung cancer. Thirty-one previously untreated patients with unresectable stage III non-small-cell lung cancer were enrolled in this study. Patients received weekly irinotecan plus carboplatin (20 mg m 72 daily for 5 days a week) for 4 weeks and thoracic radiotherapy (60 Gy in 30 fractions). The irinotecan dose was escalated from 30 mg m 72 in increments of 10 mg m 72 . Four irinotecan dose levels were given and 30 patients were assessable. Their median age was 62 years (range: 52 -72 years), 28 had a performance status of 0 -1 and two had a performance status of 2, 12 had stage IIIA disease and 18 had IIIB disease. There were 19 squamous cell carcinomas, 10 adenocarcinomas, and one large cell carcinoma. The dose-limiting toxicities were pneumonitis, esophagitis, thrombocytopenia and neutropenia. The maximum tolerated dose of irinotecan was 60 mg m 72 , with two patients developing grade 4 pulmonary toxicity and one patient died of pneumonitis (grade 5). The recommended dose of irinotecan was 50 mg m 72 . Other grade 3 or 4 toxicities were nausea and vomiting. Three patients achieved complete remission and 15 had partial remission, for an objective response rate of 60.0%. The median survival time was 14.9 months, and the 1-and 2-year survival rates were 51.6% and 34.2%, respectively. The study concluded that the major toxicity of this regimen was pneumonitis. This therapy may be active against unresectable non-small-cell lung cancer and a phase II study is warranted.

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“…Some randomised trials showed improved survival with this approach (Dillman et al, 1990;LeChevalier et al, 1992), however others could not demonstrate the value of induction chemotherapy (Cullen et al, 1991;Mattson et al, 1991;Morton et al, 1991). A new approach would be simultaneous administration of chemotherapy and radiation therapy.…”

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confidence: 99%

Continuous carboplatin infusion during 6 weeks' radiotherapy in locally inoperable non-small-cell lung cancer: A phase I and pharmacokinetic study

1996

Lung Cancer

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Thoracic Radiation Therapy Alone Compared with Combined Chemoradiotherapy for Locally Unresectable Non-Small Cell Lung Cancer

Abstract: Chemotherapy with MACC, in combination with thoracic radiotherapy, did not result in significant survival advantage compared with radiation alone (P greater than 0.2) in patients with medically inoperable or unresectable stage III non-small cell lung cancer.

Cited by 176 publications

References 16 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

Dose-escalation study of weekly irinotecan and daily carboplatin with concurrent thoracic radiotherapy for unresectable stage III non-small cell lung cancer

Continuous carboplatin infusion during 6 weeks' radiotherapy in locally inoperable non-small-cell lung cancer: A phase I and pharmacokinetic study

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