Significance of Hypofractionated Radiotherapy in Postoperative Irradiation for Breast Cancer: An Asian Multi-institutional Prospective Study.

AIMS: There is a need for the adequate distribution of healthcare resources in Southeast Asia. Many countries in the region have more patients with advanced breast cancer who are eligible for postmastectomy radiotherapy (PMRT). Therefore, it is critical that hypofractionated PMRT is effective in most of these patients. This study investigated the significance of postoperative hypofractionated radiotherapy in patients with breast cancer, including advanced breast cancer, in these countries. MATERIALS AND METHODS: Eighteen facilities in 10 Asian countries participated in this prospective, interventional, single-arm study. The study included two independent regimens: hypofractionated whole-breast irradiation (WBI) for patients who had undergone breast-conserving surgery and hypofractionated PMRT for patients who had undergone total mastectomy at a dose of 43.2 Gy in 16 fractions. In the hypofractionated WBI group, patients with high-grade factors received additional 8.1 Gy boost irradiation sessions for the tumour bed in three fractions. RESULTS: Between February 2013 and October 2019, 227 and 222 patients were enrolled in the hypofractionated WBI and hypofractionated PMRT groups, respectively. The median follow-up periods in the hypofractionated WBI and hypofractionated PMRT groups were 61 and 60 months, respectively. The 5-year locoregional control rates were 98.9% (95% confidence interval 97.4-100.0) and 96.3% (95% confidence interval 93.2-99.4) in the hypofractionated WBI and hypofractionated PMRT groups, respectively. Regarding adverse events, grade 3 acute dermatitis was observed in 2.2% and 4.9% of patients in the hypofractionated WBI and hypofractionated PMRT groups, respectively. However, no other adverse events were observed. CONCLUSION: Although further follow-up is required, hypofractionated radiotherapy regimens for postoperative patients with breast cancer in East and Southeast Asian countries are effective and safe. In particular, the proven efficacy of hypofractionated PMRT indicates that more patients with advanced breast cancer can receive appropriate care in these countries. Hypofractionated WBI and hypofractionated PMRT are reasonable approaches that can contain cancer care costs in these countries. Long-term observation is required to validate our findings.

Treatment options in bulky stage IB cervical carcinoma.

Cervical cancer is the most common female cancer in the developing countries. Treatments of bulky stage IB cervical cancer have been challenged as the local control is relatively poor compared to smaller stage I disease, whether treated by radical surgery or irradiation. The treatment options are definitive concurrent chemoradiation therapy or radical surgery with or without neoadjuvant or adjuvant therapy. The treatment decision is based on the patients' status and preferences, tumor characteristics, and experiences of clinician. This study will review and compare the treatment modalities and rationales of a combination of treatment including surgery, radiation therapy, and chemotherapy for bulky stage IB cervical carcinoma.

Chemotherapy as an adjunct to radiotherapy in locally advanced nasopharyngeal carcinoma.

BACKGROUND: A previous meta-analysis investigated the role of chemotherapy in head and neck locally advanced carcinoma. This work had not been performed on nasopharyngeal carcinoma. OBJECTIVES: The aim of the project was to study the effect of adding chemotherapy to radiotherapy on overall survival (OS) and event-free survival (EFS) in patients with nasopharyngeal carcinoma. SEARCH STRATEGY: We searched MEDLINE (1966 to October 2003), EMBASE (1980 to October 2003) and the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 3, 2003) and trial registers. Handsearches of meeting abstracts, references in review articles and of the Chinese medical literature were carried out. Experts and pharmaceutical companies were asked to identify trials. SELECTION CRITERIA: Randomised trials comparing chemotherapy plus radiotherapy to radiotherapy alone in locally advanced nasopharyngeal carcinoma were included. DATA COLLECTION AND ANALYSIS: The meta-analysis was based on updated individual patient data. The log rank test, stratified by trial, was used for comparisons and the hazard ratios (HR) of death and failure (loco-regional/distant failure or death) were calculated. MAIN RESULTS: Eight trials with 1753 patients were included. One trial with a 2 x 2 design was counted twice in the analysis. The analysis was performed including 11 comparisons based on 1975 patients. The median follow up was six years. The pooled hazard ratio of death was 0.82 (95% confidence interval (CI) 0.71 to 0.95; P = 0.006) corresponding to an absolute survival benefit of 6% at five years from chemotherapy (from 56% to 62%). The pooled hazard ratio of tumour failure or death was 0.76 (95% CI 0.67 to 0.86; P < 0.00001) corresponding to an absolute event-free survival benefit of 10% at five years from chemotherapy (from 42% to 52%). A significant interaction was observed between chemotherapy timings and overall survival (P = 0.005), explaining the heterogeneity observed in the treatment effect (P = 0.03) with the highest benefit from concomitant chemotherapy. AUTHORS' CONCLUSIONS: Chemotherapy led to a small but significant benefit for overall survival and event-free survival. This benefit was essentially observed when chemotherapy was administered concomitantly with radiotherapy.

Randomized trials of amifostine and radiotherapy: effect on survival?

Amifostine (Ethyol; MedImmune Inc, Gaithersburg, MD) is a cytoprotective and radioprotective agent for normal tissues against the deleterious effects of chemotherapeutic agents and/or ionizing radiation. We have compiled a unique database for meta-analysis that aims to address the controversial concept of the tumor protection. The proposed meta-analysis on survival outcome, which is based on individual patient data, will be more useful than literature-based meta-analyses because of the superiority of reliable, longer follow-up patient data. It will be also possible to study the effect(s) of amifostine in different tumor types.

Phase II study of concurrent gemcitabine and radiotherapy in locally advanced stage IIIB cervical carcinoma.

OBJECTIVE: The aims of this phase II study were to investigate the feasibility, efficacy, and safety of gemcitabine in combination with radiation in chemonaive patients with advanced cervical cancer. METHODS: Nineteen patients with advanced stage IIIB cervical cancer received 300 mg/m2 of gemcitabine once weekly with concurrent standard radiotherapy, 5000 cGy, for 5 weeks including one insertion of brachytherapy. RESULTS: A complete response was observed in 17 (89.5%) of the 19 eligible patients at the end of the third month after completing radiation therapy; 1 patient had a partial response while another showed no response. Adverse events of grade 3 or higher included 1 case each of diarrhea (1/19) and anemia (1/19). Other minor complications (grade 1/2) were cystitis in 8 cases (12 cycles), proctitis in 2 cases (4 cycles), nausea and vomiting in 8 cases (8 cycles), diarrhea in 8 cases (19 cycles), and anemia in 8 cases (40 cycles). At 1 year, 16 patients (84.2%) showed good control of disease, while 2 cases had residual disease and 1 had distant metastasis. Grade 3 cystitis and grade 1-2 proctitis were seen in 1 and 2 cases, respectively. After a median follow-up time of 19.9 months, the results show a disease-free survival of 84.2% and overall survival of 100%. CONCLUSIONS: Gemcitabine and concurrent radiation is well tolerated and effective for the treatment of cervical cancer. Further study of this regimen should concentrate on the dosage and the sequence of administration. The combination of gemcitabine with other chemotherapeutic agents should also be investigated.