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Duluth, MN, United States

Roy V.,Mayo Clinic Florida | Allred J.B.,Mayo Medical School | Nikcevich D.,Duluth CCOP | Mattar B.,Wichita CCOP | Perez E.A.,Mayo Clinic Florida
American Journal of Clinical Oncology: Cancer Clinical Trials | Year: 2013

Objective: We conducted a multicenter phase II trial to assess the efficacy and toxicity of docetaxel and carboplatin combination as neoadjuvant therapy for stage II or III breast cancer (BC). Methods: Patients received 75 mg/m 2 of docetaxel and AUC 6 of carboplatin on day 1 followed by pegfilgrastim on day 2, every 14 days for 4 cycles, followed by definitive breast surgery. The primary endpoint was the proportion of patients achieving pathologic complete remission (pCR), defined as disappearance of all invasive and in situ tumors in the breast and axilla after chemotherapy. Results: A total of 57 women (median age, 53 y) were enrolled. Thirtyeight (67%) had ER+ , 31 (54%) PR+ , and 6 (11%) HER2 + disease; 9 had triple negative BC (TNBC). Forty-three (75%; 95% confidence interval, 62%-86%) of 57 eligible patients had clinical response (15 clinical complete response, 28 clinical partial response). Nine (16%; 90% confidence interval, 10%-28%) patients achieved pCR. Four of 9 (44%) patients with TNBC achieved pCR. Thrombocytopenia (5%) was the only grade 4 adverse event. The most common grade 3 adverse events were thrombocytopenia (19%), fatigue (12%), and anemia (9%). Conclusions: Four cycles of 2-weekly Docetaxel and Carboplatin are feasible with acceptable toxicity and a pCR rate of 16%. This regimen can be considered for neoadjuvant therapy of BC, particularly for patients not eligible for anthracycline therapy. A high pCR rate of 44% noted in a subset of patients with TNBC is encouraging and needs to be validated in large prospective trials. Copyright © 2012 by Lippincott Williams & Wilkins.

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.

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.

Jaeckle K.A.,Mayo Clinic Florida | Ballman K.V.,Mayo Medical School | Giannini C.,Mayo Medical School | Schomberg P.J.,Mayo Medical School | And 13 more authors.
Journal of Neuro-Oncology | Year: 2010

Irinotecan has radiosensitizing effects and shows synergism with nitrosoureas. We performed a Phase II study of RT and irinotecan, followed by BCNU plus irinotecan in newly-diagnosed GBM. The MTD for patients receiving enzyme-inducing anticonvulsants (EIAC) was as follows: irinotecan 400 mg/m 2/week on Days 1, 8, 22 and 29 during RT, followed by BCNU 100 mg/m2 Day 1, and irinotecan, 400 mg/m2 on Days 1, 8, 22 and 29, every 6 weeks. The MTD for non-EIAC patients was as follows: irinotecan 125 mg/m2/week on Days 1, 8, 22 and 29 during RT, followed by BCNU 100 mg/m2 Day 1 and irinotecan 75 mg/m2 Days 1, 8, 22 and 29, every 6 weeks. Median OS was 10.8 mos. (95% CI: 7.7-14.9); OS at 12 months was 44.6% (95% CI: 33.3-59.8) and PFS 6 was 28.6% (95% CI: 18.9-43.2). Patients went off treatment due to adverse events (7%), refusal (11%), progressive disease (48%), death (9%), and other (9%); 16% completed protocol treatment. Survival was similar in patients with variant (6/7 or 7/7) and wild-type (6/6) UGT1A1*28 genotypic alleles. Grade 3-4 toxicity was more common in non-EIAC patients with variant alleles. SN-38 Cmax and AUC in EIAC patients receiving 400 mg/m2 irinotecan were 20.9 ng/ml and 212 ng/ml h, and in non-EIAC patients receiving 125 mg/m2, 15.5 ng/ml and 207 ng/ml h. SN-38 AUC varied by UGT1A1*28 status in non-EIAC patients. This regimen was not significantly active and radiosensitization was not observed. Non-EIAC patients with UGT1A1*28 variant alleles appear particularly sensitive to toxicity from irinotecan. © 2010 Springer Science+Business Media, LLC.

Jatoi A.,Mayo Medical School | Ritter H.L.,Toledo Community Hospital Oncology Program CCOP | Dueck A.,Mayo Medical School | Nguyen P.L.,Mayo Medical School | And 4 more authors.
Lung Cancer | Year: 2010

Purpose: This study tested whether infliximab, a chimeric IgG1kappa monoclonal antibody that blocks tumor necrosis factor (TNF) alpha, improves/stabilizes weight loss in elderly and/or poor performance status patients with metastatic non-small cell lung cancer (NSCLC). Methods: This double-blind trial randomly assigned patients to infliximab/docetaxel (n=32) versus placebo/docetaxel (n=29). The primary endpoint was ≥10% weight gain. Results: Groups were balanced with respect to age, number of prior chemotherapy regimens, baseline weight loss, and performance status. No patient gained ≥10% baseline weight, and early evidence of the lack of efficacy prompted early trial closure. Appetite improvement was negligible in both arms. However, infliximab-/docetaxel-treated patients developed greater fatigue and worse global quality of life scores. Other outcomes, such as tumor response rate (<10% in both groups) and overall survival, were not statistically different between groups. There were no statistically significant differences in adverse events, although one death was attributed to infliximab. Genotyping for the TNF alpha -238 and -308 polymorphisms revealed no clinical significance of these genotypes, as relevant to the loss of weight or appetite. Conclusions: This trial closed early because infliximab did not prevent or palliate cancer-associated weight loss. Infliximab was associated with increased fatigue and inferior global quality of life. © 2009 Elsevier Ireland Ltd.

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