Pemetrexed, Carboplatin, and Concomitant Radiation followed by Surgery for Locally Advanced Esophageal Cancer: Results of a Planned Interim Toxicity Analysis of North Central Cancer Treatment Group Study N044E
Purpose This brief report describes a planned, interim, 6-patient toxicity analysis that confirms the safety of pemetrexed, carboplatin, radiation with subsequent surgery, as prescribed in the North Central Cancer Treatment Group trial N044E, in patients with locally advanced esophageal cancer. Meth...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2008-01-01
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| Series: | Clinical Medicine Insights: Oncology |
| Online Access: | https://doi.org/10.4137/CMO.S444 |
| _version_ | 1828762729692790784 |
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| author | Rajini Katipamula Aminah Jatoi M.D. Nathan R. Foster Francis Nichols Joseph Rubin Matthew Callister Leonard Gunderson Steven Alberts |
| author_facet | Rajini Katipamula Aminah Jatoi M.D. Nathan R. Foster Francis Nichols Joseph Rubin Matthew Callister Leonard Gunderson Steven Alberts |
| author_sort | Rajini Katipamula |
| collection | DOAJ |
| description | Purpose This brief report describes a planned, interim, 6-patient toxicity analysis that confirms the safety of pemetrexed, carboplatin, radiation with subsequent surgery, as prescribed in the North Central Cancer Treatment Group trial N044E, in patients with locally advanced esophageal cancer. Methods Six patients with locally advanced, potentially resectable esophageal cancer received pemetrexed 500 mg/m 2 and carboplatin AUC = 6 on days 1 and 22 with 5040 centigray of concomitant radiation in 28 fractions over 5.5 weeks followed by esophagectomy as a prelude to a phase II multi-institutional trial. Results Only 1 of the 6 patients experienced a grade 4 adverse event (neutropenia). This patient also experienced a grade 3 depression. Of the remaining 5 patients, three experienced at least one grade 3 adverse event (neutropenia, nausea/vomiting, and esophagitis). There were no deaths. Incidentally, one patient manifested a complete pathologic response, three a partial pathologic response, and one stable disease. Conclusion These preliminary observations on safety suggest that this regimen can be further studied in this clinical setting. |
| first_indexed | 2024-12-11T01:48:46Z |
| format | Article |
| id | doaj.art-6b27b406226c4cdaa13f83df8d6d620f |
| institution | Directory Open Access Journal |
| issn | 1179-5549 |
| language | English |
| last_indexed | 2024-12-11T01:48:46Z |
| publishDate | 2008-01-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Clinical Medicine Insights: Oncology |
| spelling | doaj.art-6b27b406226c4cdaa13f83df8d6d620f2022-12-22T01:24:48ZengSAGE PublishingClinical Medicine Insights: Oncology1179-55492008-01-01210.4137/CMO.S444Pemetrexed, Carboplatin, and Concomitant Radiation followed by Surgery for Locally Advanced Esophageal Cancer: Results of a Planned Interim Toxicity Analysis of North Central Cancer Treatment Group Study N044ERajini Katipamula0Aminah Jatoi M.D.1Nathan R. Foster2Francis Nichols3Joseph Rubin4Matthew Callister5Leonard Gunderson6Steven Alberts7Department of Oncology, Mayo Clinic, Rochester, Minnesota.Department of Oncology, Mayo Clinic, Rochester, Minnesota.Division of Biostatistics, Mayo Clinic, Rochester, Minnesota.Division of Thoracic Surgery, Mayo Clinic, Rochester, Minnesota.Department of Oncology, Mayo Clinic, Rochester, Minnesota.Department of Radiation Oncology, Mayo Clinic, Scottsdale, Arizona.Department of Radiation Oncology, Mayo Clinic, Scottsdale, Arizona.Department of Oncology, Mayo Clinic, Rochester, Minnesota.Purpose This brief report describes a planned, interim, 6-patient toxicity analysis that confirms the safety of pemetrexed, carboplatin, radiation with subsequent surgery, as prescribed in the North Central Cancer Treatment Group trial N044E, in patients with locally advanced esophageal cancer. Methods Six patients with locally advanced, potentially resectable esophageal cancer received pemetrexed 500 mg/m 2 and carboplatin AUC = 6 on days 1 and 22 with 5040 centigray of concomitant radiation in 28 fractions over 5.5 weeks followed by esophagectomy as a prelude to a phase II multi-institutional trial. Results Only 1 of the 6 patients experienced a grade 4 adverse event (neutropenia). This patient also experienced a grade 3 depression. Of the remaining 5 patients, three experienced at least one grade 3 adverse event (neutropenia, nausea/vomiting, and esophagitis). There were no deaths. Incidentally, one patient manifested a complete pathologic response, three a partial pathologic response, and one stable disease. Conclusion These preliminary observations on safety suggest that this regimen can be further studied in this clinical setting.https://doi.org/10.4137/CMO.S444 |
| spellingShingle | Rajini Katipamula Aminah Jatoi M.D. Nathan R. Foster Francis Nichols Joseph Rubin Matthew Callister Leonard Gunderson Steven Alberts Pemetrexed, Carboplatin, and Concomitant Radiation followed by Surgery for Locally Advanced Esophageal Cancer: Results of a Planned Interim Toxicity Analysis of North Central Cancer Treatment Group Study N044E Clinical Medicine Insights: Oncology |
| title | Pemetrexed, Carboplatin, and Concomitant Radiation followed by Surgery for Locally Advanced Esophageal Cancer: Results of a Planned Interim Toxicity Analysis of North Central Cancer Treatment Group Study N044E |
| title_full | Pemetrexed, Carboplatin, and Concomitant Radiation followed by Surgery for Locally Advanced Esophageal Cancer: Results of a Planned Interim Toxicity Analysis of North Central Cancer Treatment Group Study N044E |
| title_fullStr | Pemetrexed, Carboplatin, and Concomitant Radiation followed by Surgery for Locally Advanced Esophageal Cancer: Results of a Planned Interim Toxicity Analysis of North Central Cancer Treatment Group Study N044E |
| title_full_unstemmed | Pemetrexed, Carboplatin, and Concomitant Radiation followed by Surgery for Locally Advanced Esophageal Cancer: Results of a Planned Interim Toxicity Analysis of North Central Cancer Treatment Group Study N044E |
| title_short | Pemetrexed, Carboplatin, and Concomitant Radiation followed by Surgery for Locally Advanced Esophageal Cancer: Results of a Planned Interim Toxicity Analysis of North Central Cancer Treatment Group Study N044E |
| title_sort | pemetrexed carboplatin and concomitant radiation followed by surgery for locally advanced esophageal cancer results of a planned interim toxicity analysis of north central cancer treatment group study n044e |
| url | https://doi.org/10.4137/CMO.S444 |
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