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East Chattanooga, TN, United States

Hainsworth J.D.,Sarah Cannon Research Institute | Hainsworth J.D.,Tennessee Oncology PLLC | Rubin M.S.,Florida Cancer Specialists | Arrowsmith E.R.,Chattanooga Oncology Hematology Associates | And 3 more authors.
Clinical Genitourinary Cancer | Year: 2013

Background: This phase II trial examined the activity and toxicity of second-line treatment with pazopanib after failure of first-line single-agent treatment with sunitinib or bevacizumab in patients with advanced clear cell renal carcinoma. Patients and Methods: Fifty-five patients with metastatic clear cell renal carcinoma who had previously received first-line treatment with sunitinib (39 patients) or bevacizumab (16 patients) were enrolled. Patients received pazopanib 800 mg orally daily and were evaluated for response after 8 weeks of treatment. Responses were measured using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0, and confirmed with repeated scans after 8 weeks. Patients with objective response or stable disease continued treatment until disease progression or unacceptable toxicity occurred. Results: Fifteen of 55 patients (27%) had objective response to pazopanib. An additional 27 patients (49%) had stable disease, for a disease control rate of 76%. After a median follow-up of 16.7 months, the median progression-free survival for the entire group was 7.5 months (95% confidence interval, 5.4-9.4 months). Similar progression-free survival was observed regardless of whether previous treatment was with sunitinib or bevacizumab. The estimated overall survival rate for the entire group at 24 months was 43%. Conclusion: Pazopanib is an active agent for the treatment of advanced clear cell renal carcinoma, even after failure of sunitinib or bevacizumab. Treatment with pazopanib should be considered early in the sequence of therapy for patients with advanced renal cell carcinoma. © 2013 Elsevier Inc. Source

Yardley D.,Sarah Cannon Research Institute | Yardley D.,Tennessee Oncology PLLC | Zubkus J.,Tennessee Oncology PLLC | Daniel B.,Chattanooga Oncology Hematology Associates | And 8 more authors.
Clinical Breast Cancer | Year: 2010

Background: Neoadjuvant anthracycline/taxane combinations, with or without gemcitabine, produce pathologic complete responses (pCRs) in 15%-25% of patients. In this multicenter phase II study, we attempted to increase efficacy and decrease toxicity of a 3-drug gemcitabine-containing neoadjuvant regimen by administering dose-dense therapy with pegfilgrastim, and including albumin-bound paclitaxel as the taxane. Patients and Methods: A total of 123 patients with locally advanced breast cancer were enrolled. Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy. Results: A total of 116 patients (95%) completed neoadjuvant chemotherapy and had subsequent surgical resection. Twenty-three patients (20%) had a pCR. The estimated 3-year progression-free survival (PFS) and overall survival rates were 48% and 86%, respectively. Neoadjuvant treatment was well tolerated; only 11% of the patients had grade 3/4 neutropenia, with 1 episode of neutropenic fever. Other grade 3/4 toxicities occurred in < 10% of the patients. Conclusion: Neoadjuvant biweekly chemotherapy with gemcitabine/epirubicin/albumin-bound paclitaxel with pegfilgrastim is feasible and well tolerated. The pCR rate of 20% and the 3-year PFS rate of 48% are similar to results achieved with other commonly used neoadjuvant regimens. Source

Yardley D.A.,Sarah Cannon Research Institute | Yardley D.A.,Tennessee Oncology PLLC | Burris H.A.,Sarah Cannon Research Institute | Burris H.A.,Tennessee Oncology PLLC | And 7 more authors.
Clinical Breast Cancer | Year: 2011

Purpose: Preclinical models suggest that addition of anti-vascular endothelial growth factor therapy may improve the efficacy of anti-estrogens in hormone-sensitive breast cancer. This phase II trial evaluated the feasibility and efficacy of bevacizumab added to either anastrozole or fulvestrant in the first-line treatment of patients who have hormone receptor-positive metastatic breast cancer. Methods: Women who had newly diagnosed metastatic hormone receptor-positive breast cancer were eligible. Patients who had relapsed while receiving, or ≤ 12 months after receiving, adjuvant aromatase inhibitor therapy were treated with bevacizumab (10 mg/kg intravenously every 2 weeks) and fulvestrant (loading dose 500 mg intramuscularly [IM], then 250 mg IM 2 weeks later, then 250 mg IM every 4 weeks). All other patients received fulvestrant/bevacizumab or anastrozole (1 mg orally daily)/bevacizumab. Patients who were HER2-positive could also receive trastuzumab (8 mg/kg loading dose, then 6mg/kg every 3 weeks). Patients were reevaluated after 8 weeks of therapy; responding or stable patients continued treatment until disease progression or unacceptable toxicity. Results: Seventy-nine patients were enrolled (38 were administered anastrozole 41 fulvestrant). Median treatment duration was 8 months in the anastrozole group and 5.5 months in the fulvestrant group. Both regimens were efficacious: overall response rate and median progression-free survival for the entire group were 28% and 13.5 months, respectively. Both regimens were well-tolerated; toxicity was consistent with the known toxicity profiles of each single agent. Conclusion: Bevacizumab combined with either anastrozole or fulvestrant was feasible and active in the first-line treatment of patients who have hormone receptor-positive metastatic breast cancer. Phase III trials evaluating the efficacy of bevacizumab added to endocrine therapy are in progress. © 2011 Elsevier Inc. All rights reserved. Source

Yardley D.A.,Sarah Cannon Research Institute | Yardley D.A.,Tennessee Oncology PLLC | Daniel D.,Chattanooga Oncology Hematology Associates | Stipanov M.,Chattanooga Oncology Hematology Associates | And 6 more authors.
Cancer Investigation | Year: 2010

We investigated the feasibility/efficacy of oxaliplatin in combination with trastuzumab as first-/second-line treatment of HER2-positive metastatic breast cancer (MBC). Patients received oxaliplatin/trastuzumab every 21 days and were evaluated every 6 weeks using RECIST criteria. The study closed early due to slow accrual. Twenty-five patients were evaluable; of these, 5 (20%) had objective responses to oxaliplatin/trastuzumab. Therapy was well tolerated (no grade-4 and gastrointestinal grade-3 toxicity in 4% of patients), but had only modest activity (median time-to-progression 1.8 months). Substitution of oxaliplatin for cisplatin or carboplatin, in combination with trastuzumab, does not appear to improve first-/second-line therapy in HER2-positive MBC. © 2010 Informa Healthcare USA, Inc. Source

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