Abstract | BACKGROUND: PATIENTS AND METHODS: Patients with resected Dukes' stage B or C rectal cancer were treated with a combination of raltitrexed and radiotherapy (50.4 Gy at 1.8 Gy per fraction over five to six weeks). At least three patients were treated at each of three escalating raltitrexed dose levels (2.0, 2.6 and 3.0 mg/m2) once every three weeks. Toxicity was assessed by the recording of WHO adverse events and biochemistry and haematology determinations. RESULTS: A total of 22 patients entered the study, 17 of whom had Dukes' stage C disease. All three patients entered at a dose level of 3.0 mg/m2 experienced dose-limiting toxicity (DLT) (2 patients had grade 3 leucopenia and 1 patient had grade 2 leucopenia and grade 3 diarrhoea); however, only 2 of 1 patients entered at a dose level of 2.6 mg/m2 experienced DLT (1 patient had grade 4 neutropenia and 1 patient died probably due to aspiration pneumonia unrelated to treatment). The most common haematological toxic events were leucopenia (8 patients) and anaemia (6 patients). Only four haematological or biochemical toxic events were of grade 3 or 4. Other common toxicities were diarrhoea and nausea, which occurred in 15 and 9 patients, respectively. CONCLUSIONS: This study demonstrates that raltitrexed can be combined with postoperative radiotherapy for treatment of patients with Dukes' stage B or C rectal cancer. The recommended dose of raltitrexed in this setting is 2.6 mg/m2, which is close to the full monotherapy dose.
|
Authors | N Botwood, R James, C Vernon, P Price |
Journal | Annals of oncology : official journal of the European Society for Medical Oncology
(Ann Oncol)
Vol. 11
Issue 8
Pg. 1023-8
(Aug 2000)
ISSN: 0923-7534 [Print] England |
PMID | 11038040
(Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Antimetabolites, Antineoplastic
- Quinazolines
- Thiophenes
- raltitrexed
|
Topics |
- Adult
- Aged
- Antimetabolites, Antineoplastic
(administration & dosage, adverse effects)
- Chemotherapy, Adjuvant
- Combined Modality Therapy
- Dose-Response Relationship, Drug
- Female
- Humans
- Male
- Middle Aged
- Neutropenia
(chemically induced)
- Pneumonia
(chemically induced)
- Quinazolines
(administration & dosage, adverse effects)
- Radiotherapy, Adjuvant
- Rectal Neoplasms
(drug therapy, radiotherapy, surgery)
- Thiophenes
(administration & dosage, adverse effects)
- Treatment Outcome
|