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Deming R.L.,Iowa Oncology Research Association CCOP | Tai T.H.P.,Allan Blair Cancer Center
Supportive Care in Cancer | Year: 2013

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. © 2012 Springer-Verlag Berlin Heidelberg.

Uhm J.H.,Mayo Medical School | Ballman K.V.,Mayo Medical School | Wu W.,Mayo Medical School | Giannini C.,Mayo Medical School | And 9 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2011

Purpose: Amplification of the epidermal growth factor receptor (EGFR) gene represents one of the most frequent gene alterations in glioblastoma (GBM). In the current study, we evaluated gefitinib, a potent EGFR inhibitor, in the treatment of adults with newly diagnosed GBM. Methods and Materials: Ninety-eight patients (96 evaluable) were accrued between May 18, 2001, and August 2, 2002. All were newly diagnosed GBM patients who were clinically and radiographically stable/improved after radiation treatment (enrollment within 5 weeks of radiation completion). No prior chemotherapy was permitted. EGFR amplification/mutation, as assessed by fluorescence in situ hybridization and immunohistochemistry, was not required for treatment with gefitinib but was studied when tissues were available. Gefitinib was administered at 500 mg each day; for patients receiving dexamethasone or enzyme-inducing (CYP3A4) agents, dose was escalated to a maximum of 1,000 mg QD. Treatment cycles were repeated at 4-week intervals with brain magnetic resonance imaging at 8-week intervals. Results: Overall survival (OS; calculated from time of initial surgery) at 1 year (primary end point) with gefitinib was 54.2%, which was not statistically different compared with that of historical control population (48.9%, data from three previous Phase III North Central Cancer Treatment Group studies of newly diagnosed GBM patients). Progression-free survival (PFS) at 1 year post-RT (16.7%) was also not significantly different to that of historical controls (30.3%). Clinical outcome was not affected by EGFR status (amplification or vIII mutation). Fatigue (41%), rash (62%), and loose stools (58%) constituted the most frequent adverse events, the majority of these being limited to Grade 1/2. Of note, the occurrence of drug-related adverse effects, such as loose stools was associated with improved OS. Conclusions: In our evaluation of nearly 100 patients with newly diagnosed GBM, treatment with adjuvant gefitinib post-radiation was not associated with significant improvement in OS or PFS. However, patients who experienced gefitinib-associated adverse effects (rash/diarrhea) did demonstrate improved OS. © 2011 Elsevier Inc.

Schild S.E.,Mayo Medical School | Behl D.,Mayo Medical School | Markovic S.N.,Mayo Medical School | Brown P.D.,Mayo Medical School | And 4 more authors.
American Journal of Clinical Oncology: Cancer Clinical Trials | Year: 2010

Objectives: This study was performed to evaluate the addition of temozolomide (TMZ) to whole brain radiotherapy (WBRT) for brain metastases from melanoma. Methods: Seven patients with brain metastases from melanoma were treated on a North Central Cancer Treatment Group (NCCTG) trial (N0274) of TMZ plus WBRT. TMZ was given orally in doses of 200 mg/m2 for 5 days every 4 weeks for up to 8 cycles. WBRT was started on the first day of TMZ and included the delivery of 3750 cGy in 15 fractions. In addition, separately analyzed was a cohort of 53 patients treated at the Mayo Clinic who received WBRT alone (39 patients) or WBRT plus TMZ (14 patients). Results: The median survival of the 7 patients treated on N0274 was 3.6 months with 2 of 7 (29%) failing in brain and 5 of 7 (71%) failing elsewhere. For the other cohort of 53 patients, the median survival was 3.8 months with WBRT alone compared 4.3 months for WBRT plus TMZ (P = 0.5). Conclusions: Patients did not appear to benefit from the addition of TMZ to WBRT for the treatment of their brain metastases. Further improvements in outcome will require research to discover more effective systemic therapy and RT techniques. © 2010 by Lippincott Williams & Wilkins.

Mc Kean H.,Mayo Medical School | Stella P.J.,Michigan Cancer Research Consortium | Hillman S.L.,Mayo Medical School | Rowland Jr. K.M.,Carle Cancer Center | And 6 more authors.
Cancer Investigation | Year: 2011

How do oncologists choose therapy for the elderly? Oncologists assigned patients aged 65 years or older with incurable non-small cell lung cancer to: (a) carboplatin (AUC = 2) + paclitaxel 50 mg/m2 days 1, 8, 15 (28-day cycle ×A - 4) followed by gefitinib; or (b) gefitinib 250 mg/day. With (a), 12 of 34 were progression-free at 6 months; median time to cancer progression was 3.9 months. With (b), the same occurred in 11 of 28 patients with the latter being 4.9 months. The most common reason for conventional chemotherapy was oncologists opinion that the cancer was aggressive, and for gefitinib alone, patients reluctance to receive chemotherapy. Interestingly, age had no influence. Copyright © 2011 Informa Healthcare USA, Inc.

Jatoi A.,Mayo Medical School | Soori G.,Missouri Valley Cancer Consortium | Foster N.R.,Mayo Medical School | Hiatt B.K.,Iowa Oncology Research Association CCOP | And 4 more authors.
Journal of Thoracic Oncology | Year: 2010

Based on favorable preliminary clinical data and the need to identify effective, well-tolerated neoadjuvant regimens for patients with locally advanced esophageal cancer, this clinical trial was undertaken. Methods: This phase II study tested 500 mg/m2 neoadjuvant pemetrexed intravenously and carboplatin with an area under the curve of 6 intravenously on days 1 and 22 in conjunction with concomitant radiation of 5040 centigray, which was given in 28 daily fractions of 180 centigray. The primary endpoint was the rate of pathologic complete response. Results: This trial closed early because, during an interim analysis, the primary endpoint fell short. However, 26 eligible patients were accrued. Twenty (74%) were men. Performance scores of 0, 1, and 2 were seen in 16 (59%), 9 (33%), and 2 (7%), respectively. Among eligible patients, 6 of 26 (23%; 95% confidence interval 9-44%) demonstrated a pathologic complete response. Twenty-two underwent a complete cancer resection. The median survival was 17.8 months (95% confidence interval: 12.2-30.7 months). In the neoadjuvant setting, 22 patients had at least one grade 3 or worse adverse event, and 8 patients had at least one grade 4 event. Postoperatively (within 30 days of surgery), there were three deaths, one grade 4 event (thrombosis), and three grade 3 events. Conclusions: The neoadjuvant regimen tested within this phase II trial demonstrated antineoplastic activity but fell short of yielding a complete pathologic response rate that merits further testing. Copyright © 2010 by the International Association for the Study of Lung Cancer.

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