Gerald Clamon

Publications (8)44.09 Total impact

• Article: Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer.

  Anne Aupérin, Cecile Le Péchoux, Estelle Rolland, Walter J Curran, Kiyoyuki Furuse, Pierre Fournel, Jose Belderbos, Gerald Clamon, Hakki Cuneyt Ulutin, Rebecca Paulus, Takeharu Yamanaka, Marie-Cecile Bozonnat, Apollonia Uitterhoeve, Xiaofei Wang, Lesley Stewart, Rodrigo Arriagada, Sarah Burdett, Jean-Pierre Pignon
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  ABSTRACT: The previous individual patient data meta-analyses of chemotherapy in locally advanced non-small-cell lung cancer (NSCLC) showed that adding sequential or concomitant chemotherapy to radiotherapy improved survival. The NSCLC Collaborative Group performed a meta-analysis of randomized trials directly comparing concomitant versus sequential radiochemotherapy. Systematic searches for trials were undertaken, followed by central collection, checking, and reanalysis of updated individual patient data. Results from trials were combined using the stratified log-rank test to calculate pooled hazard ratios (HRs). The primary outcome was overall survival; secondary outcomes were progression-free survival, cumulative incidences of locoregional and distant progression, and acute toxicity. Of seven eligible trials, data from six trials were received (1,205 patients, 92% of all randomly assigned patients). Median follow-up was 6 years. There was a significant benefit of concomitant radiochemotherapy on overall survival (HR, 0.84; 95% CI, 0.74 to 0.95; P = .004), with an absolute benefit of 5.7% (from 18.1% to 23.8%) at 3 years and 4.5% at 5 years. For progression-free survival, the HR was 0.90 (95% CI, 0.79 to 1.01; P = .07). Concomitant treatment decreased locoregional progression (HR, 0.77; 95% CI, 0.62 to 0.95; P = .01); its effect was not different from that of sequential treatment on distant progression (HR, 1.04; 95% CI, 0.86 to 1.25; P = .69). Concomitant radiochemotherapy increased acute esophageal toxicity (grade 3-4) from 4% to 18% with a relative risk of 4.9 (95% CI, 3.1 to 7.8; P < .001). There was no significant difference regarding acute pulmonary toxicity. Concomitant radiochemotherapy, as compared with sequential radiochemotherapy, improved survival of patients with locally advanced NSCLC, primarily because of a better locoregional control, but at the cost of manageable increased acute esophageal toxicity.
  Journal of Clinical Oncology 03/2010; 28(13):2181-90. · 18.37 Impact Factor
• Article: Concomitant radio-chemotherapy (RT-CT) versus sequential RT-CT in locally advanced non-small cell lung cancer (NSCLC): A meta-analysis using individual patient data (IPD) from randomised clinical trials (RCTs): A1-05

  Anne Auperin, Estelle Rolland, Walter J. Curran, Kiyoyuki Furuse, Pierre Fournel, Jose Belderbos, Gerald Clamon, Hakk Cüneyt Ulutin, Lesley Stewart, Cécile Le Pechoux
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  ABSTRACT: An abstract is unavailable. This article is available as HTML full text and PDF.
  Journal of Thoracic Oncology 07/2007; 2(8):S310. · 3.66 Impact Factor
• Article: Concurrent chemoradiotherapy for unresectable stage III non-small cell lung cancer.

  Everett E Vokes, Jeffrey Crawford, Jeffrey Bogart, Mark A Socinski, Gerald Clamon, Mark R Green
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  ABSTRACT: Over the last two decades, several approaches to multimodality therapy have been investigated in patients with advanced unresectable non-small cell lung cancer. These include induction chemotherapy and concurrent chemoradiotherapy. Both approaches have been shown to be superior to radiation therapy alone. However, in several randomized trials, concomitant chemoradiotherapy was shown to be superior to the induction chemotherapy approach. It has been hypothesized that the addition of systemic dose sequential chemotherapy to concurrent chemoradiotherapy, either as induction or as consolidation chemotherapy, might further improve survival rates. Recently, the Cancer and Leukemia Group B reported on a randomized phase III trial directly evaluating the addition of two cycles of carboplatin and paclitaxel to concurrent chemoradiotherapy. In this study, induction chemotherapy failed to further improve survival rates of concurrent chemoradiotherapy. A previously conducted randomized phase II study also suggested no benefit from the addition of induction chemotherapy to concomitant chemoradiotherapy. Favorable phase II data have been published supporting the use of consolidation chemotherapy. However, to date, no large randomized study evaluating a possible benefit from consolidation chemotherapy has been completed. In addition to evaluating optimal sequencing strategies of combined modality therapy, current investigations are also focusing on the integration of novel agents, including chemotherapeutic and targeted therapies. Currently ongoing trials involving novel approaches are reviewed here.
  Clinical Cancer Research 08/2005; 11(13 Pt 2):5045s-5050s. · 7.74 Impact Factor
• Article: Lack of trastuzumab activity in nonsmall cell lung carcinoma with overexpression of erb-B2: 39810: a phase II trial of Cancer and Leukemia Group B.

  Gerald Clamon, James Herndon, Jeffrey Kern, Ramaswamy Govindan, Jennifer Garst, Dorothy Watson, Mark Green
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  ABSTRACT: The overexpression of HER-2 occurs in a minority of patients with nonsmall cell lung carcinoma. Trastuzumab, which is a monoclonal antibody to HER-2, is an effective treatment in some women with breast carcinomas that overexpress HER-2, as demonstrated by immunohistochemistry. The objective of this Phase II study was to determine whether trastuzumab would effect responses in patients with nonsmall cell lung carcinoma who had tumors that overexpressed HER-2. Patients were required to have Stage IIIB or Stage IV nonsmall cell lung carcinoma and tumors with 2+ or 3+ expression of HER-2, as determined with immunohistochemistry, and they may have received up to 1 prior chemotherapy regimen. Trastuzumab at a dose of 4 mg/kg was given intravenously on Week 1; then, weekly doses of 2 mg/kg were given. Response revaluation was performed every 8 weeks. Among 209 screened patients, 24 patients (11%) had tumors with 2+ or 3+ expression of HER-2. One patient achieved a partial response, and one patient experienced a treatment-related death due to pulmonary toxicity. Single-agent trastuzumab did not exhibit significant clinical activity against nonsmall cell lung carcinoma when HER-2 expression levels were measured by immunohistochemistry.
  Cancer 05/2005; 103(8):1670-5. · 4.77 Impact Factor
• Source

  Available from: omegal-omega-3.com

  Article: Phase II study of high-dose fish oil capsules for patients with cancer-related cachexia.

  C Patrick Burns, Susan Halabi, Gerald Clamon, Ellen Kaplan, Raymond J Hohl, James N Atkins, Michael A Schwartz, Brett A Wagner, Electra Paskett
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  ABSTRACT: The authors undertook a multiinstitutional Phase II cooperative group study to examine the potential of oral fish oil fatty acid supplements administered at high doses to slow weight loss and to improve quality of life in patients with malignancy-related cachexia. Patients with advanced malignancy and weight loss > or = 2% of body weight in the preceding month took concentrated, high-dose omega-3 fatty acid capsules (7.5 g eicosapentaenoic acid plus docosahexaenoic acid for a 70 kg individual) that were supplied by the National Institutes of Health. Forty-three patients with moderate or severe malnutrition were enrolled. The median time receiving treatment was 1.2 months. For the 36 patients who took at least 1 capsule and did not have edema, there was a weight change ranging from -6.2 kg to +3.5 kg and an overall median weight loss of 0.8 kg. Twenty-four patients had weight stabilization (a gain of < or = 5% or a loss of < 5%), 6 patients gained > 5% of their body weight, and 6 patients lost > or = 5% of their body weight. There was marked variability in the tolerability of the capsules, and many patients had gastrointestinal side effects. There was a correlation between time receiving treatment and weight gain for the 22 patients who were able to tolerate the capsules for at least 1 month. Quality-of-life scores were superior for patients who gained weight. A majority of patients did not gain weight, and in that sense, the results of the study were unfavorable. However, a small but definite subset of patients had weight stabilization or weight gain. This suggests that omega-3 fatty acids have potential utility at the study doses, which were more than twice the doses used in published Phase III studies.
  Cancer 08/2004; 101(2):370-8. · 4.77 Impact Factor
• Article: Therapy choices among older patients with lung carcinoma: an evaluation of two trials of the Cancer and Leukemia Group B.

  Caio Max S Rocha Lima, James E Herndon, Michael Kosty, Gerald Clamon, Mark R Green
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  ABSTRACT: Despite a greater risk of malignancy and a higher cancer mortality rate for patients age > 65 years, bias in accruing older patients to clinical trials persists. The results from two National Cancer Institute-approved cooperative group trials (Cancer and Leukemia Group B trial 8931 [CALGB 8931] and CALGB 9130) were analyzed retrospectively to determine the participation, tolerance of treatment, and outcome of patients age > 70 years. Five hundred fifteen patients with locally advanced or metastatic nonsmall cell lung carcinoma participated in two separate, randomized, Phase III clinical trials conducted by CALGB. Retrospective evaluation of patients by four distinct age cohorts (< 50 years, 50-59 years, 60-69 years, and > 70 years) was carried out to determine differences in toxicity, response, and survival. No patients age > 80 were entered on either study, even though there was no age restriction in the study eligibility criteria. No significant differences were seen in response, survival, or continuation of treatment based on age cohort. Significantly increased leukocyte toxicity was seen in older cohorts without a concomitant increase in severe or worse infectious events. No patients age > 80 were entered on either trial despite their potential eligibility. Patients in the oldest cohort showed no negative impact of age on treatment tolerance, response to treatment, or survival. The aggregate clinical judgment of patients and physicians can identify septuagenarians who should not be denied active consideration for aggressive management of their advanced nonsmall cell lung carcinoma.
  Cancer 01/2002; 94(1):181-7. · 4.77 Impact Factor
• Article: A phase III trial of etoposide and cisplatin in extensive small cell lung cancer: A cancer and Leukemia Group B study

  Edith P. Mitchell, Michael C. Perry, Sharon D. Luikart, Constance T. Cirrincione, David A. Van Echo, James E. Herndon II, L. Herbert Maurer, Gerald Clamon, Mark R. Green
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  ABSTRACT: Patients with untreated extensive small cell lung cancer (SCLC) with CALGB performance scores 0–2 were treated with etoposide 200 mg/m2/day on days 1–3 and cisplatin doses of 20, 30, or 35 mg/m2/day days 1–3 in a Phase format. Of the nine patients treated at the 35 mg/m2/day cisplatin dose in the Phase I portion of the study, Grade 4 leukopenia occurred in five patients and Grade 4 thrombocytopenia in four. There were two deaths due to myelosuppression and sepsis. This dose was thus considered the maximum tolerated dose (MTD), and a Phase II trial was then conducted using this treatment program. In the Phase II trial of 39 patients, the objective response rate was 67% (95% confidence interval, 50–81%) with 21% complete responses (CI 9–36%). Median survival was 10.5 months. Grade 4–5 leukopenia was seen in 57% and Grade 4–5 thrombocytopenia in 56%. The MTD defined by this Phase I trial represents a 67–100% increase in etoposide and a 33–42% increase in cisplatin dosage compared to prior studies. The observed objective response rates with this regimen are comparable to studies using conventional doses, but hematological toxicity was higher.
  Lung Cancer. 15(2):215-223.
• Article: A phase III trial of etoposide and cisplatin in extensive small cell lung cancer: A cancer and Leukemia Group B study

  Edith P. Mitchell, Michael C. Perry, Sharon D. Luikart, Constance T. Cirrincione, David A. Van Echo, James E. Herndon, L. Herbert Maurer, Gerald Clamon, Mark R. Green
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  ABSTRACT: Patients with untreated extensive small cell lung cancer (SCLC) with CALGB performance scores 0–2 were treated with etoposide 200 mg/m2/day on days 1–3 and cisplatin doses of 20, 30, or 35 mg/m2/day days 1–3 in a Phase format. Of the nine patients treated at the 35 mg/m2/day cisplatin dose in the Phase I portion of the study, Grade 4 leukopenia occurred in five patients and Grade 4 thrombocytopenia in four. There were two deaths due to myelosuppression and sepsis. This dose was thus considered the maximum tolerated dose (MTD), and a Phase II trial was then conducted using this treatment program. In the Phase II trial of 39 patients, the objective response rate was 67% (95% confidence interval, 50–81%) with 21% complete responses (CI 9–36%). Median survival was 10.5 months. Grade 4–5 leukopenia was seen in 57% and Grade 4–5 thrombocytopenia in 56%. The MTD defined by this Phase I trial represents a 67–100% increase in etoposide and a 33–42% increase in cisplatin dosage compared to prior studies. The observed objective response rates with this regimen are comparable to studies using conventional doses, but hematological toxicity was higher.
  Lung Cancer.