An Updated Analysis of the Survival Endpoints of ASCENDE-RT.

PURPOSE: Using the primary endpoint of time to biochemical progression (TTP), Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (ASCENDE-RT) randomized National Comprehensive Cancer Network patients with intermediate and high-risk prostate cancer to low-dose-rate brachytherapy boost (LDR-PB) or dose-escalated external beam boost (DE-EBRT). Randomization to the LDR-PB arm resulted in a 2-fold reduction in biochemical progression compared with the DE-EBRT group at a median follow-up of 6.5 years (P < .001). Herein, the primary endpoint and secondary survival endpoints of the ASCENDE-RT trial are updated at a 10-year median follow-up. METHODS: Patients were randomly assigned to either the LDR-PB or the DE-EBRT arm (1:1). All patients received 1 year of androgen deprivation therapy and 46 Gy in 23 fractions of pelvic RT. Patients in the DE-EBRT arm received an additional 32 Gy in 16 fractions, and those in the LDR-PB arm received an 125I implant prescribed to a minimum peripheral dose of 115 Gy. Two hundred patients were randomized to the DE-EBRT arm and 198 to the LDR-PB arm. RESULTS: The 10-year Kaplan-Meier TTP estimate was 85% ± 5% for LDR-PB compared with 67% ± 7% for DE-EBRT (log rank P < .001). Ten-year time to distant metastasis (DM) was 88% ± 5% for the LDR-PB arm and 86% ± 6% for the DE-EBRT arm (P = .56). There were 117 (29%) deaths. Ten-year overall survival (OS) estimates were 80% ± 6% for the LDR-PB arm and 75% ± 7% for the DE-EBRT arm (P = .51). There were 30 (8%) patients who died of prostate cancer: 12 (6%) in the LDR-PB arm, including 2 treatment-related deaths, and 18 (9%) in the DE-EBRT arm. CONCLUSIONS: Men randomized to the LDR-PB boost arm of the ASCENDE-RT trial continue to experience a large advantage in TTP compared with those randomized to the DE-EBRT arm. ASCENDE-RT was not powered to detect differences in its secondary survival endpoints (OS, DM, and time to prostate cancer-specific death) and none are apparent.

Spiritual care in a multicultural oncology environment.

PURPOSE OF REVIEW: Increasingly, oncology is practiced within multicultural environments. All aspects of care, including spiritual care should be delivered to patients with cancer in a culturally sensitive manner. In this article, we discuss the influence of culture on patients with cancer throughout the disease process by highlighting relevant reports in the literature. RECENT FINDINGS: Most articles focussing on culture and oncology are single-author or single-institution narrative reports pertaining to experiences with an individual racial, ethnic, religious or minority patient group. The majority of articles are found within the palliative care and nursing literature. SUMMARY: Health-related values vary widely across cultures, and the experience of spiritual care in oncology differs greatly across cultural groups. Although culture is generally recognized as an important health determinant that impacts the experience of care, the extent of different cultural influences is not well understood due to a paucity of relevant data, and reports on resources and educational strategies to optimize culturally competent spiritual care are similarly lacking.

Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis.

BACKGROUND: The National Cancer Institute of Canada Clinical Trials Group undertook a multicenter, randomized, double-blind controlled trial of an oral antimicrobial versus placebo to prevent and treat mucositis. We present the quality of life (QOL) analysis for this trial. METHODS: One hundred thirty-eight patients were randomly assigned. QOL data were collected every 2 weeks before, during, and after radiotherapy. The European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30) and a Trial Specific Checklist (TSC) were used. RESULTS: The antimicrobial lozenge did not impact QOL. The principal acute side effect of radiotherapy is oral pain, affecting more than 90% of patients. Role function is impacted during treatment, and patients experience fatigue. Appetite was reported to markedly increase during radiotherapy. There was a dramatic and persistent increase in dry mouth. CONCLUSIONS: This study highlights the benefits of combining the EORTC QLQ-30 with an "oral" TSC in a randomized controlled trial and provides valuable baseline data for their use with an objective mucositis scoring system.