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Loprinzi C.L.,Alliance Statistics and Data Center | Qin R.,Alliance Statistics and Data Center | Dakhil S.R.,Wichita Community Clinical Oncology Program | Fehrenbacher L.,Kaiser Permanente | And 6 more authors.
Journal of Clinical Oncology | Year: 2014

Purpose: Cumulative neurotoxicity is a prominent toxicity of oxaliplatin-based therapy. Intravenous calcium and magnesium have been extensively used to reduce oxaliplatin-induced neurotoxicity. This trial was designed to definitively test whether calcium/magnesium decreases oxaliplatin-related neurotoxicity. Patients and Methods: In all, 353 patients with colon cancer undergoing adjuvant therapy with FOLFOX (fluorouracil, leucovorin, and oxaliplatin) were randomly assigned to intravenous calcium/magnesium before and after oxaliplatin, a placebo before and after, or calcium/magnesium before and placebo after. The primary end point was cumulative neurotoxicity measured by the sensory scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy- Induced Peripheral Neuropathy 20 tool. Results: There were no statistically significant neuropathy differences among the study arms as measured by the primary end point or additional measures of neuropathy, including clinician-determined measurement of the time to grade 2 neuropathy by using the National Cancer Institute Common Terminology Criteria for Adverse Events scale or an oxaliplatin-specific neuropathy scale. In addition, calcium/magnesium did not substantially decrease oxaliplatininduced acute neuropathy. Conclusion: This study does not support using calcium/magnesium to protect against oxaliplatin-induced neurotoxicity. © 2013 by American Society of Clinical Oncology.

Jatoi A.,Mayo Medical School | Dakhil S.R.,Wichita Community Clinical | Sloan J.A.,Mayo Medical School | Kugler J.W.,Illinois Oncology Research Association | And 6 more authors.
Supportive Care in Cancer | Year: 2011

Purpose: Previous studies suggest tetracycline and other antibiotics lessen the severity of epidermal growth factor receptor (EGFR) inhibitor-induced rash. This study sought to confirm such findings. Methods: Patients starting an EGFR inhibitor were eligible for this randomized, double-blinded, placebo-controlled study and had to be rash-free. They were then randomly assigned to tetracycline 500 mg orally twice a day for 28 days versus a placebo. Rash development and severity (monthly physician assessment and weekly patient-reported questionnaires), quality of life (SKINDEX-16), and adverse events were monitored during the 4-week intervention and then for an additional 4 weeks. The primary objective was to compare the incidence of grade 2 or worse rash between study arms; 32 patients per group provided a 90% probability of detecting a 40% difference in incidence with a type I error rate of 0.05 (two-sided). Results: Sixty-five patients were enrolled, and groups were balanced on baseline characteristics. During the first 4 weeks, healthcare provider-reported data found that 27 tetracycline-treated patients (82%) and 24 placebo-exposed patients (75%) developed a rash. This rash was a grade 2+ in 17 (52%) and 14 (44%), respectively (p=0.62). Comparable grade 2+ rash rates were observed during weeks 5 through 8 as well as with patient-reported rash data throughout the study period. Quality of life was comparable across study arms, and tetracycline was well tolerated. Conclusion: Although previous studies suggest otherwise, this randomized, double-blinded, placebo-controlled study did not find that tetracycline lessened rash incidence or severity in patients who were taking EGFR inhibitors. © 2010 Springer-Verlag.

Jatoi A.,Mayo Medical School | Foster N.R.,Mayo Medical School | Egner J.R.,Carle Cancer Center | Burch P.A.,Mayo Medical School | And 6 more authors.
International Journal of Oncology | Year: 2010

Whether elderly patients with metastatic esophageal, gastroesophageal, and gastric cancer do as well with chemotherapy as their younger counterparts was investigated in this pooled analysis. In total, 367 patients from 8 consecutive, first-line trials were included: i) etoposide + cisplatin; ii) 5-fluorourucil + leucovorin; iii) 5-fluorouracil + levamisole; iv) irinotecan; v) docetaxel + irinotecan; vi) oxaliplatin + capecitabine; vii) docetaxel + capecitabine; and viii) bortezomib + paclitaxel + carboplatin. One hundred and fifty-four (42%) patients were ≥65 years old (range: 65-86), and 213 younger (range: 20-64). Elderly patients had worse performance scores (2-3): 19 vs. 8% (p<0.0001). Rates of grade 3+ adverse events across all chemotherapy cycles in univariate and multivariate analyses (adjusted for gender, performance score, and stratified by individual study) were higher among elderly patients. Rates of neutropenia, fatigue, infection, and stomatitis in elderly vs. younger patients were 31 vs. 29% (p=0.02 by multivariate analyses); 15 vs. 5% (p=0.01); 9 vs. 4% (p=0.03); 6 vs. 1% (p=0.04). In contrast, duration of chemotherapy, overall survival, and progression-free survival were comparable. Although age should not preclude trial entry, these adverse event rates suggest a need to develop more tolerable regimens for older patients with these malignancies.

Moraska A.R.,Mayo Medical School | Atherton P.J.,Metro Minnesota Community Clinical Oncology Program | Szydlo D.W.,Michigan Cancer Research Consortium | Barton D.L.,Carle Cancer Center | And 5 more authors.
Journal of Supportive Oncology | Year: 2010

Hot flashes are a complication of androgen deprivation therapy for prostate cancer. A phase III study showed that use of low-dose gabapentin was well tolerated and moderately decreased the frequency of hot flashes due to androgen deprivation therapy when taken for 4 weeks. The current study, an open-label continuation of the randomized study, examined the efficacy and toxicity of gabapentin when taken for (an additional) 8 weeks. Patients were allowed to start, or continue, gabapentin and to titrate the dose to maximum efficacy, up to 900 mg/d. They were asked to complete a hot flash diary daily and keep weekly logs of toxicity, satisfaction with hot flash control, and quality of life. The moderate reduction in hot flash frequency and severity in the randomized phase of the study appeared to be maintained during this continuation phase. Men originally receiving the placebo or lowest dose of gabapentin (300 mg/d) had improved hot flash control relative to that at the end of the randomized phase. Minimal adverse effects were reported. These findings suggest that low-dose gabapentin is moderately efficacious for at least 12 weeks of hot flash treatment in men undergoing androgen deprivation therapy for prostate cancer and seems to be well tolerated. (NCT00028572) © 2010 Elsevier Inc.

Barton D.L.,Mayo Medical School | Soori G.S.,Missouri Valley Cancer Consortium | Bauer B.A.,Mayo Medical School | Sloan J.A.,Mayo Medical School | And 8 more authors.
Supportive Care in Cancer | Year: 2010

Purpose This pilot trial sought to investigate whether any of three doses of American ginseng (Panax quinquefolius) might help cancer-related fatigue. A secondary aim was to evaluate toxicity Methods Eligible adults with cancer were randomized in a double-blind manner, to receive American ginseng in doses of 750, 1, 000, or 2, 000 mg/day or placebo given in twice daily dosing over 8 weeks. Outcome measures included the Brief Fatigue Inventory, vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36), and the Global Impression of Benefit Scale at 4 and 8 weeks. Results Two hundred ninety patients were accrued to this trial. Nonsignificant trends for all outcomes were seen in favor of the 1, 000- and 2, 000-mg/day doses of American ginseng. Area under the curve analysis of activity interference from the Brief Fatigue Inventory was 460-467 in the placebo group and 750 mg/day group versus 480-551 in the 1, 000- and 2, 000-mg/day arms, respectively. Change from baseline in the vitality subscale of the SF-36 was 7.3- 7.8 in the placebo and the 750-mg/day arm, versus 10.5-14.6 in the 1, 000- and 2, 000-mg/day arms. Over twice as many patients on ginseng perceived a benefit and were satisfied with treatment over those on placebo. There were no significant differences in any measured toxicities between any of the arms. Conclusion There appears to be some activity and tolerable toxicity at 1, 000-2, 000 mg/day doses of American ginseng with regard to cancer-related fatigue. Thus, further study of American ginseng is warranted. © US Government 2009.

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