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Spigel D.R.,Sarah Cannon Research Institute | Spigel D.R.,Methodist Estabrook Cancer Center | Spigel D.R.,Genentech | Spigel D.R.,University of North Carolina at Chapel Hill | And 36 more authors.
Journal of Clinical Oncology | Year: 2011

Purpose: Because of promising efficacy signals in single-arm studies, a placebo-controlled, double-blind, randomized phase II trial was designed to assess the efficacy and safety of adding bevacizumab to first-line standard chemotherapy for treatment of extensive-stage small-cell lung cancer (SCLC). Patients and Methods: Patients with SCLC were randomly assigned to receive bevacizumab or placebo, with cisplatin or carboplatin plus etoposide, for four cycles followed by single-agent bevacizumab or placebo until progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). Results: Fifty-two patients were randomly assigned to the bevacizumab group and 50 to the placebo group; 69% versus 66%, respectively, completed four cycles of therapy. Median PFS was higher in the bevacizumab group (5.5 months) than in the placebo group (4.4 months; hazard ratio [HR], 0.53; 95% CI, 0.32 to 0.86). Median overall survival (OS) was similar for both groups (9.4 v 10.9 months for bevacizumab and placebo groups, respectively), with an HR of 1.16 (95% CI, 0.66 to 2.04). Overall response rates were 58% (95% CI, 43% to 71%) for the bevacizumab group and 48% (95% CI, 34% to 62%) for the placebo group. Median duration of response was 4.7 months for the bevacizumab group and 3.2 months for the placebo group. In the bevacizumab and placebo groups, 75% versus 60% of patients, respectively, experienced one or more grade 3 or higher adverse events. No new or unexpected safety signals for bevacizumab were observed. Conclusion: The addition of bevacizumab to cisplatin or carboplatin plus etoposide for treatment of extensive-stage SCLC improved PFS, with an acceptable toxicity profile. However, no improvement in OS was observed. © 2011 by American Society of Clinical Oncology.

Hughes B.,Prince Charles Hospital | Hughes B.,Royal Brisbane Hospital | Mileshkin L.,Peter MacCallum Cancer Center | Townley P.,Methodist Estabrook Cancer Center | And 9 more authors.
Oncologist | Year: 2014

Background. Combination blockade of human epidermal growth factor receptor (HER) family signaling may confer enhanced antitumor activity than single-agent blockade. We performed a single-arm study of pertuzumab, a monoclonal antibody that inhibits HER2 dimerization, and erlotinib in relapsed non-small cell lung cancer (NSCLC). Methods. Patients received pertuzumab (840-mg loading dose and 420-mg maintenance intravenously every 3 weeks) and erlotinib (150-mg or 100-mg dose orally, daily). The primary endpoint was response rate (RR) by 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) at day 56 in all patients and those with EGFR wild-type tumors. Results. Of 41 patients, 28 (68.3%) experienced treatment-related grade ≥3 adverse events, including pneumatosis intestinalis (3 patients), resulting in early cessation of enrollment. Tissue samples from 32 patients showed mutated EGFR status in 9 of 41 (22%) and wild-type EGFR in 23 of 41 (56%). The FDG-PET RR for patients with assessments at day 56 was 19.5% in all patients (n = 41) and 8.7% in patients with wild-type EGFR NSCLC (n = 23). Investigator-assessed computed tomography RR at day 56 was 12.2%. Conclusion. FDG-PET suggests that pertuzumab plus erlotinib is an active combination, but combination therapy was poorly tolerated, which limits its clinical applicability. More research is warranted to identify drug combinations that disrupt HER receptor signaling but that exhibit improved tolerability profiles. © AlphaMed Press 2014.

PubMed | Methodist Estabrook Cancer Center
Type: Journal Article | Journal: Journal of applied clinical medical physics | Year: 2016

Metal implants which saturate the CT number scale may require dosimetrist and physicist involvement to manually contour and assign an appropriate value to the metal for accurate dose calculation. This study investigated dose calculation based directly on extended CT scale images for different metals and geometries. The aim was to evaluate extended CT accuracy as a suitable alternative to standard CT methods in the presence of high-Z materials and artifacts, despite the reduced HU resolution of extended CT. Gafchromic film measurements were made for comparison to calculated doses. The method of direct dose calculation on extended CT scale was compared to our institutions standard method of manually contouring and assigning metal values on saturated CT images for each of the metal samples. Clinical patient plans with metal implants were investigated and DVHs were compared between standard CT and extended CT dose calculations. Dose calculations showed agreement within 2% between the two methods of metal characterization and the film measurement in the case of the strongest metal attenuator, cobalt-chromium. In the clinical treatment plans, the greatest dose discrepancy between the two methods was 1.2%. This study suggests that direct dose calculation on an extended scale CT image in the presence of metal implants can produce accurate clinically viable treatment plans, thereby improving efficiency of clinical workflow and eliminating a potential source of human error by manual CT number assignment.

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