ABSTRACT
PURPOSE: The Bowel Function Questionnaire (BFQ) has been used in clinical trials to assess symptoms during and after pelvic radiotherapy (RT). This study evaluated the importance of symptoms in the BFQ from a patient perspective. METHODS: Patients reported presence or absence of symptoms and rated importance of symptoms at baseline, 4 weeks after completion of pelvic RT, and 12 and 24 months after RT. The BFQ measured overall quality of life (QOL) and symptoms of nocturnal bowel movements, incontinence, clustering, need for protective clothing, inability to differentiate stool from gas, liquid bowel movements, urgency, cramping, and bleeding. Bowel movement frequency also was recorded. A content validity questionnaire (CVQ) was used to rate symptoms as "not very important," "moderately unimportant," "neutral," "moderately important," or "very important." RESULTS: Most of the 125 participating patients rated all symptoms as moderately or very important. Generally, patients gave similar ratings for symptom importance at all study points, and ratings were independent of whether the patient experienced the symptom. Measures of greatest importance (moderately or very important) at baseline were ability to control bowel movements (94 %), not having to wear protective clothing (90 %), and not having rectal bleeding (94 %). With the exception of need for protective clothing, the presence of a symptom at 4 weeks was associated with significantly worse QOL (P < .01 for all). CONCLUSIONS: The BFQ has excellent content validity. Patients rated most symptoms as moderately or very important, indicating the BFQ is an appropriate tool for symptom assessment during and after pelvic RT.
Subject(s)
Diarrhea/prevention & control , Gastrointestinal Agents/therapeutic use , Intestines/radiation effects , Octreotide/therapeutic use , Pelvic Neoplasms/radiotherapy , Diagnostic Self Evaluation , Diarrhea/psychology , Female , Humans , Intestines/physiopathology , Male , Middle Aged , Pelvic Neoplasms/psychology , Pelvis , Quality of Life , Surveys and Questionnaires , United StatesABSTRACT
PURPOSE: To assess the effectiveness of depot octreotide for the prevention of diarrhea during pelvic radiation therapy. PATIENTS AND METHODS: Patients receiving pelvic radiation therapy (planned minimum dose, 45 Gy; 1.7 to 2.1 Gy daily) were eligible for the study. From May 10, 2002, through October 14, 2005, 125 patients were randomly allocated in a double-blind fashion to receive octreotide (100 microg, administered subcutaneously on day 1, followed by depot octreotide, 20 mg, administered intramuscularly on days 2 and 29; n = 62) or to receive a placebo (n = 63). RESULTS: Grade 0, 1, 2, and 3 diarrhea were observed in 18%, 31%, 31%, and 21% of patients in the octreotide arm, respectively, and in 25%, 32%, 22%, and 21% of patients in the placebo arm, respectively (P = .64). Grade 0, 1, 2, and 3 abdominal cramps were observed in 32%, 45%, 21%, and 2% of patients receiving octreotide, respectively, and in 51%, 24%, 21%, and 5% of patients receiving the placebo, respectively (P = .053). Some patient-reported symptoms were worse in the octreotide group, including nocturnal bowel movements (70% v 45%; P = .004), clustering of bowel movements (90% v 69%; P = .004), and bleeding with bowel movements (57% v 35%; P = .01). CONCLUSION: As administered in this study, octreotide did not decrease diarrhea during pelvic radiation therapy. Some gastrointestinal symptoms were worse in patients treated with octreotide. Octreotide is not indicated for prevention of diarrhea during pelvic radiation therapy.
Subject(s)
Antidiarrheals/administration & dosage , Diarrhea/prevention & control , Octreotide/administration & dosage , Pelvic Neoplasms/radiotherapy , Radiation Injuries/prevention & control , Acute Disease , Antidiarrheals/adverse effects , Delayed-Action Preparations , Diarrhea/etiology , Double-Blind Method , Female , Humans , Injections, Intramuscular , Injections, Subcutaneous , Male , Octreotide/adverse effects , Radiation Injuries/etiology , Radiotherapy/adverse effects , Radiotherapy Dosage , Severity of Illness Index , Time Factors , Treatment FailureABSTRACT
PURPOSE: To investigate the therapeutic usefulness and cost-effectiveness of prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer (SCLC) who had achieved a complete remission. METHODS: A retrospective chart review was undertaken of all patients diagnosed in Saskatchewan with SCLC between 1987 and 1998 inclusive. Patients who achieved a complete remission were divided into two groups, depending on whether they underwent PCI (PCI+ and PCI-, respectively). The quality-of-life-adjusted survival was estimated by the Q-TWiST method (quality time without symptoms and toxicity). The mean incremental costs per month of incremental OS were calculated in a cost-effectiveness analysis. RESULTS: Among the 98 complete remission patients, the median OS for PCI+ and PCI- patients was 20.0 and 19.0 months, respectively (p > 0.05, nonsignificant). The median disease-free survival was 14.7 and 10.0 months, respectively (p < 0.05). The difference in the mean Q-TWiST survival was significant (p < 0.01). The mean marginal cost was $18,834/PCI+ patient and $17,885/PCI- patient (p > 0.05, nonsignificant). The cost-effectiveness ratio was $70/mo of incremental OS if u(tox) and u(rel) (the utility coefficients to reflect the value of time in health states of toxicity and relapse) were assumed to be 1.0. CONCLUSION: PCI is a cost-effective treatment that improves the quality-of-life-adjusted survival for patients with a complete remission of SCLC.
