RTOG 0017: A Phase I Trial of Concurrent Gemcitabine/Carboplatin or Gemcitabine/Paclitaxel and Radiation Therapy ('Ping-Pong Trial') Followed By Adjuvant Chemotherapy for Patients with Favorable Prognosis Inoperable Stage IIIA/B Non-small Cell Lung Cancer
| Autor: | David S. Ettinger, Anshu K. Jain, Walter J. Curran, G. Whipple, W. Demas, Hak Choy, Jennifer Moughan |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Oncology
Male Lung Neoplasms medicine.medical_treatment NSCLC Deoxycytidine Carboplatin Cohort Studies chemistry.chemical_compound Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols Aged 80 and over Remission Induction Radiotherapy Dosage Middle Aged Prognosis Combined Modality Therapy Survival Rate Treatment Outcome Chemoradiation Area Under Curve Female medicine.drug Adult Pulmonary and Respiratory Medicine medicine.medical_specialty Maximum Tolerated Dose Paclitaxel Neutropenia Internal medicine medicine Humans Lung cancer Aged Neoplasm Staging Chemotherapy business.industry medicine.disease Gemcitabine Radiation therapy Regimen chemistry Concurrent chemoradiation Non small cell lung cancer business Febrile neutropenia Follow-Up Studies |
| Zdroj: | Journal of Thoracic Oncology. 4(1):80-86 |
| ISSN: | 1556-0864 |
| DOI: | 10.1097/jto.0b013e318191503f |
| Popis: | Purpose: The optimal dose of gemcitabine that can be used with concurrent radiation therapy for locally advanced non-small cell lung cancer has not been well defined. This trial addresses this question in an alternating sequence “ping-pong” design trial to find the maximum tolerated dose (MTD) for gemcitabine/carboplatin (Sequence A) or gemcitabine/paclitaxel (Sequence B) and thoracic radiation therapy followed by adjuvant gemcitabine/carboplatin chemotherapy. Patients and Methods: Thirty-five patients with histologically confirmed Stage IIIA/B non-small cell lung cancer were entered into two separate sequences, each with multiple cohorts. A dose level was considered acceptable if, of the first six eligible patients on each cohort, fewer than three experienced dose limiting toxicities. Results: Sequence B of this 2 sequence “ping-pong” trial closed early due to toxicity in cohort 2 (gemcitabine 300 mg/m 2 /wk and paclitaxel 30 mg/m 2 /wk). On Sequence A, the MTD was the cohort 5 dose: gemcitabine 450 mg/m 2 /wk and carboplatin 2 area under curve (AUC) concurrently with thoracic radiation. Cohort 7 (gemcitabine 600 mg/m 2 /wk and carboplatin 2 AUC) showed 4 dose limiting toxicities: 2 grade 3 esophagitis; one grade 3 febrile neutropenia; and one grade 4 neutropenia. Conclusion: Concurrent gemcitabine/paclitaxel chemoradiation regimen followed by adjuvant gemcitabine/carboplatin produced excessive toxicity at the lowest tested dose combination and was not suitable for further study in this trial. Meanwhile, the MTD of concurrent gemcitabine/carboplatin chemoradiation was determined to be gemcitabine 450 mg/m 2 and carboplatin AUC-2. This combination was found to be tolerable. Although not a primary end point, survival results are summarized as well. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|