Hershman D.L.,Columbia University |
Lacchetti C.,American Society of Clinical Oncology |
Dworkin R.H.,University of Rochester |
Lavoie Smith E.M.,University of Michigan |
And 12 more authors.
Journal of Clinical Oncology | Year: 2014
Purpose: To provide evidence-based guidance on the optimum prevention and treatment approaches in the management of chemotherapy-induced peripheral neuropathies (CIPN) in adult cancer survivors. Methods: A systematic literature search identified relevant, randomized controlled trials (RCTs) for the treatment of CIPN. Primary outcomes included incidence and severity of neuropathy as measured by neurophysiologic changes, patient-reported outcomes, and quality of life. Results: A total of 48 RCTs met eligibility criteria and comprise the evidentiary basis for the recommendations. Trials tended to be small and heterogeneous, many with insufficient sample sizes to detect clinically important differences in outcomes. Primary outcomes varied across the trials, and in most cases, studies were not directly comparable because of different outcomes, measurements, and instruments used at different time points. The strength of the recommendations is based on the quality, amount, and consistency of the evidence and the balance between benefits and harms. Recommendations: On the basis of the paucity of high-quality, consistent evidence, there are no agents recommended for the prevention of CIPN. With regard to the treatment of existing CIPN, the best available data support a moderate recommendation for treatment with duloxetine. Although the CIPN trials are inconclusive regarding tricyclic antidepressants (such as nortriptyline), gabapentin, and a compounded topical gel containing baclofen, amitriptyline HCL, and ketamine, these agents may be offered on the basis of data supporting their utility in other neuropathic pain conditions given the limited other CIPN treatment options. Further research on these agents is warranted. © 2014 by American Society of Clinical Oncology.
Coon A.B.,Rush University Medical Center |
Dickler A.,Little Company of Mary Hospital |
Kirk M.C.,Massachusetts General North Shore Cancer Center |
Liao Y.,Rush University Medical Center |
And 5 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2010
Purpose: For patients with left-sided breast cancers, radiation treatment to the intact breast results in high doses to significant volumes of the heart, increasing the risk of cardiac morbidity, particularly in women with unfavorable cardiac anatomy. We compare helical tomotherapy (TOMO) and inverse planned intensity modulated radiation therapy (IMRT) with three-dimensional conformal radiotherapy using opposed tangents (3D-CRT) for reductions in cardiac volumes receiving high doses. Methods and Materials: Fifteen patients with left-sided breast cancers and unfavorable cardiac anatomy, determined by a maximum heart depth (MHD) of ≥1.0 cm within the tangent fields, were planned for TOMO and IMRT with five to seven beam angles, in addition to 3D-CRT. The volumes of heart and left ventricle receiving ≥35 Gy (V35) were compared for the plans, as were the mean doses to the contralateral breast and the volume receiving ≥20 Gy (V20) for the ipsilateral lung. Results: The mean MHD was 1.7 cm, and a significant correlation was observed between MHD and both heart and left ventricle V35. The V35s for IMRT (0.7%) and TOMO (0.5%) were significantly lower than for 3D-CRT (3.6%). The V20 for IMRT (22%) was significantly higher than for 3D-CRT (15%) or TOMO (18%), but the contralateral breast mean dose for TOMO (2.48 Gy) was significantly higher than for 3D-CRT (0.93 Gy) or IMRT (1.38 Gy). Conclusions: Both TOMO and IMRT can significantly reduce cardiac doses, with modest increases in dose to other tissues in left-sided breast cancer patients with unfavorable cardiac anatomy. © 2010 Elsevier Inc.
Niedzwiecki D.,Duke University |
Niedzwiecki D.,University of North Carolina at Chapel Hill |
Niedzwiecki D.,Dana-Farber Cancer Institute |
Niedzwiecki D.,Massachusetts General North Shore Cancer Center |
And 332 more authors.
Journal of Clinical Oncology | Year: 2011
Purpose: We conducted a randomized trial comparing adjuvant treatment with edrecolomab versus observation in patients with resected, low-risk, stage II colon cancer. This study also prospectively studied patient- and tumor-specific markers of treatment outcome. Patients and Methods: After surgical resection, patients with stage II colon cancer were randomly assigned to either five infusions of edrecolomab at 28-day intervals or observation without adjuvant therapy. Results: Final accrual included 1,738 patients; 865 patients received edrecolomab, and 873 patients were observed without adjuvant treatment. Median follow-up time was 7.9 years. There were no significant outcome differences between study arms (overall survival [OS], P = .71; disease-free survival, P = .64). The combined 5-year all-cause OS was 0.86 (95% CI, 0.84 to 0.88), and the combined 5-year disease-specific OS was 0.93 (95% CI, 0.91 to 0.94). The relationships between demographic and histopathologic factors and survival differed for all-cause and disease-specific survival outcomes, but no combined prognostic factor model was found to adequately classify patients at higher risk of recurrence or death as a result of colon cancer. Conclusion: Edrecolomab did not prolong survival. Consequently, this large study with a long duration of follow-up provided unique data concerning the natural history of resected stage II colon cancer. Prognostic factors identified in previous retrospective and pooled analyses were associated with survival outcomes in this stage II patient cohort. Results from ongoing molecular marker studies may enhance our ability to determine the risk profile of these patients. © 2011 by American Society of Clinical Oncology.