Southwest Oncology Group

Key Center, WA, United States

Southwest Oncology Group

Key Center, WA, United States
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Geneva, Switzerland, May 5, 2017 - A late breaking subanalysis of the phase III CONVERT trial presented at the European Lung Cancer Conference (ELCC) shows that white blood cell boosting drugs are safe during concurrent chemo-radiotherapy of small cell lung cancer (SCLC).1 "The optimal treatment for limited-stage SCLC is concurrent chemo-radiotherapy," said lead author Dr Fabio Gomes, a medical oncologist at the Christie NHS Foundation Trust, Manchester, UK. "The efficacy of this intensive treatment is balanced by more toxicity, mainly haematological but also oesophageal and pulmonary. Meaning this is not a treatment to be considered for every patient and many more will struggle to stay on track with the planned treatment". Granulocyte colony-stimulating factors (G-CSFs) are commonly used as a supportive measure to boost the survival, proliferation and differentiation of neutrophils. The expected neutropenia is less severe and patients recover more quickly, reducing their risk for infectious complications. However, its use during concurrent chemo-radiotherapy in SCLC is controversial and the American Society of Clinical Oncology (ASCO) recommends against its routine use.2 This is due to a randomised trial with 215 eligible patients performed between 1989 and 1991, which showed a significant increase in severe thrombocytopenia, severe anaemia, pulmonary complications and toxic deaths when granulocyte-macrophage CSFs (GM-CSFs) were used during concurrent chemo-radiotherapy.3 Gomes said: "There have been two major changes since this trial was published in 1995 which may affect the safety of CSF in this context. First, the trial tested GM-CSFs which act on more than one blood cell lineage and are not commonly used nowadays. Instead we use G-CSFs, which are more specific and aim for the neutrophil lineage only. Second, modern radiotherapy techniques have evolved significantly since then and are more precise, which reduces the risks of toxicity." The phase III CONVERT trial enrolled 547 patients with limited-stage SCLC for concurrent chemo-radiotherapy who were randomised to once-daily or twice-daily radiotherapy. There was no difference in overall survival between the two groups.4 The trial protocol allowed the use of G-CSF, and around 40% of patients received it at some point during the treatment. For the analysis presented today, the researchers compared the toxicities and outcomes between patients who received G-CSF during concurrent chemo-radiotherapy and those who did not. They confirmed that the chance of severe thrombocytopenia or anaemia during treatment almost doubled in patients given G-CSF to around 30% and 20%, respectively, however these were lower than previously reported. That was followed by a significantly higher use of further supportive measures such as platelets and blood transfusions. However, there was no difference in the incidence of pulmonary complications or in survival. Gomes said: "G-CSF had no significant negative impact on the outcomes of these patients, which is a very comforting result. The higher haematological toxicity was balanced by an appropriate supportive care throughout treatment." He continued: "We can conclude from this analysis that the use of G-CSF during thoracic radiotherapy is safe and should support patients to receive the full planned course of concurrent chemo-radiotherapy and achieve the best possible benefit. These findings should give clinicians the confidence to use G-CSF when needed in this context. We aim to publish a complete analysis later this year which may hopefully help change the current guidelines." Commenting on the findings, Dr Stefan Zimmermann, Senior Consultant, Medical Oncology Department, HFR - Hôpital Cantonal, Fribourg, Switzerland, said: "Oncologists do need G-CSF to mitigate neutropenia and increase chemotherapy delivery and compliance, but want the beneficial effect of timely concurrent therapy to outweigh the toxic risks." "In this analysis, the use of G-CSF did not result in an increased risk of pneumonitis, but the incidence of severe thrombocytopenia is a concern," he continued. "The use of G-CSF was not detrimental to progression-free survival or overall survival. We can conclude that primary or secondary prophylaxis of febrile neutropenia with G-CSF is justified, but patients at higher risk for thrombocytopenia should be treated with caution." 1 Abstract LBA2_PR - 'Use of G-CSF and prophylactic antibiotics with concurrent chemo-radiotherapy in limited-stage small cell lung cancer: results from the phase III CONVERT trial,' will be presented by Dr Fabio Gomes during the Proffered Paper session 'SCLC and early stage NSCLC' on Sunday, 7 May, 09:00 (CEST). 2 Smith TJ, et al. Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015;33(28): 3199-3212. 3 Bunn PA Jr, et al. Chemoradiotherapy with or without granulocyte-macrophage colony-stimulating factor in the treatment of limited-stage small-cell lung cancer: a prospective phase III randomized study of the Southwest Oncology Group. J Clin Oncol. 1995;13(7):1632-1641. This press release contains information provided by the authors of the highlighted abstracts and reflects the content of those abstracts. It does not necessarily reflect the views or opinions of ESMO or IASLC who cannot be held responsible for the accuracy of the data. Commentators quoted in the press release are required to comply with the ESMO Declaration of Interests policy and the ESMO Code of Conduct. The European Lung Cancer Conference (ELCC) is the reference event in Europe for professionals treating lung cancers. It is organised by the European Society for Medical Oncology and the International Association for the Study of Lung Cancer in partnership with ESTRO and ETOP. ELCC provides a comprehensive multidisciplinary overview of the latest as well as of the state-of-the-art knowledge in thoracic malignancies, covering different aspects such as prevention, screening, diagnosis, treatment modalities and the results of basic, clinical and translational research, presented by top international academic experts. Around 2,000 attendees are expected from throughout Europe and the rest of the world. About the European Society for Medical Oncology (ESMO) ESMO is the leading professional organisation for medical oncology. With more than 15,000 members representing oncology professionals from over 130 countries worldwide, ESMO is the society of reference for oncology education and information. We are committed to supporting our members to develop and advance in a fast-evolving professional environment. http://www. About the International Association for the Study of Lung Cancer (IASLC) The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated to the study of lung cancer. Founded in 1974, the association's membership includes more than 5,000 lung cancer specialists in over 100 countries. Visit http://www. for more information.

Yothers G.,N-of-One | Yothers G.,University of Pittsburgh | Sargent D.J.,Mayo Clinic Cancer Center | Sargent D.J.,North Central Cancer Treatment Group | And 13 more authors.
Journal of the National Cancer Institute | Year: 2011

Conclusion Background Among patients with resected colon cancer, black patients have worse survival than whites. We investigated whether disparities in survival and related endpoints would persist when patients were treated with identical therapies in controlled clinical trials.Conclusion Methods We assessed 14611 patients (1218 black and 13393 white) who received standardized adjuvant treatment in 12 randomized controlled clinical trials conducted in North America for resected stage II and stage III colon cancer between 1977 and 2002. Individual patient data on covariates and outcomes were extracted from the Adjuvant Colon Cancer ENdpoinTs (ACCENT) database. The endpoints examined in this meta-analysis were overall survival (time to death), recurrence-free survival (time to recurrence or death), and recurrence-free interval (time to recurrence). Cox models were stratified by study and controlled for sex, stage, age, and treatment to determine the effect of race. Kaplan-Meier estimates were adjusted for similar covariates to control for confounding. All statistical tests were two-sided.Conclusion Results Black patients were younger than whites (median age, 58 vs 61 years, respectively; P <. 001) and more likely to be female (55% vs 45%, respectively; P <. 001). Overall survival was worse in black patients than whites (hazard ratio [HR] of death = 1.22, 95% confidence interval [CI] = 1.11 to 1.34, P <. 001). Five-year overall survival rates for blacks and whites were 68.2% and 72.8%, respectively. When subsets defined by sex, stage, and age were analyzed, overall survival was consistently worse in black patients. Recurrence-free survival was worse in black patients than whites (HR of recurrence or death = 1.14, 95% CI = 1.04 to 1.24, P =. 0045). Three-year recurrence-free survival rates in blacks and whites were 68.4% and 72.1%, respectively. In contrast, recurrence-free interval was similar in black and white patients (HR of recurrence = 1.08, 95% CI = 0.97 to 1.19, P =. 15). Three-year recurrence-free interval rates in blacks and whites were 71.3% and 74.2%, respectively.Conclusion Conclusion sBlack patients with resected stage II and stage III colon cancer who were treated with the same therapy as white patients experienced worse overall and recurrence-free survival, but similar recurrence-free interval, compared with white patients. The differences in survival may be mostly because of factors unrelated to the patients' adjuvant colon cancer treatment. © The Author 2011. Published by Oxford University Press.

Twardowski P.W.,City of Hope Comprehensive Cancer Center | Twardowski P.W.,Southwest Oncology Group | Mack P.C.,Southwest Oncology Group | Mack P.C.,University of California at Davis | And 2 more authors.
Clinical Genitourinary Cancer | Year: 2014

Papillary renal cell carcinoma (pRCC) represents the second most common histologic variant of kidney cancer. It exhibits a different molecular signature than clear-cell carcinoma and is typically not associated with mutations in the VHL (von Hippel-Lindau) tumor suppressor gene. pRCC is less responsive to modern drugs introduced in the management of kidney cancer in the past decade. In this article, the heredity and biology of 2 main variants of pRCC are outlined. New targets that are being explored in the treatment of this disease are discussed, with particular emphasis on inhibition of mesenchymal epithelial transition (MET) and epidermal growth factor receptor (EGFR) pathways. We discuss preclinical data providing rationale for the combination of MET and EGFR inhibitors and review recently completed and ongoing clinical trials that attempt to expand our therapeutic options for this important subset of kidney cancer. © 2014 Elsevier Inc.

Swain S.M.,The Surgical Center | Swain S.M.,Washington Hospital Center | Jeong J.-H.,University of Pittsburgh | Geyer Jr. C.E.,The Surgical Center | And 27 more authors.
New England Journal of Medicine | Year: 2010

BACKGROUND: Chemotherapy regimens that combine anthracyclines and taxanes result in improved disease-free and overall survival among women with operable lymph-node-positive breast cancer. The effectiveness of concurrent versus sequential regimens is not known. METHODS: We randomly assigned 5351 patients with operable, node-positive, early-stage breast cancer to receive four cycles of doxorubicin and cyclophosphamide followed by four cycles of docetaxel (sequential ACT); four cycles of doxorubicin and docetaxel (doxorubicin- docetaxel); or four cycles of doxorubicin, cyclophosphamide, and docetaxel (concurrent ACT). The primary aims were to examine whether concurrent ACT was more effective than sequential ACT and whether the doxorubicin-docetaxel regimen would be as effective as the concurrent-ACT regimen. The secondary aims were to assess toxic effects and to correlate amenorrhea with outcomes in premenopausal women. Results: At a median follow-up of 73 months, overall survival was improved in the sequential-ACT group (8-year overall survival, 83%) as compared with the doxorubicin-docetaxel group (overall survival, 79%; hazard ratio for death, 0.83; P = 0.03) and the concurrent-ACT group (overall survival, 79%; hazard ratio, 0.86; P = 0.09). Disease-free survival was improved in the sequential-ACT group (8-year disease-free survival, 74%) as compared with the doxorubicin-docetaxel group (disease-free survival, 69%; hazard ratio for recurrence, a second malignant condition, or death, 0.80; P = 0.001) and the concurrent-ACT group (disease-free survival, 69%; hazard ratio, 0.83; P = 0.01). The doxorubicin-docetaxel regimen showed noninferiority to the concurrent-ACT regimen for overall survival (hazard ratio, 0.96; 95% confidence interval, 0.82 to 1.14). Overall survival was improved in patients with amenorrhea for 6 months or more across all treatment groups, independently of estrogen-receptor status. CONCLUSIONS: Sequential ACT improved disease-free survival as compared with doxorubicin-docetaxel or concurrent ACT, and it improved overall survival as compared with doxorubicin-docetaxel. Amenorrhea was associated with improved survival regardless of the treatment and estrogen-receptor status. ( number, NCT00003782.). Copyright © 2010 Massachusetts Medical Society.

Sosman J.A.,Vanderbilt University | Moon J.,Southwest Oncology Group | Tuthill R.J.,Cleveland Clinic | Warneke J.A.,University of Arizona | And 6 more authors.
Cancer | Year: 2011

BACKGROUND: On the basis of retrospective experience at individual centers, it appears that patients with stage IV melanoma who undergo complete resection have a favorable outcome compared with patients with disseminated stage IV disease. The Southwest Oncology Group (SWOG) performed a prospective trial in patients with metastatic melanoma who were enrolled before complete resection of their metastatic disease and provided prospective outcomes in the cooperative group setting. METHODS: Based on their physical examination and radiologic imaging studies, patients with a stage IV melanoma judged amenable to complete resection underwent surgery within 28 days of enrollment. All eligible patients were followed with scans (computed tomography or positron emission tomography) every 6 months until relapse and death. RESULTS: Seventy-seven patients were enrolled from 18 different centers. Of those, 5 patients were ineligible; 2 had stage III disease alone; and 3 had no melanoma in their surgical specimen. In addition, 8 eligible patients had incompletely resected tumor. Therefore, the primary analysis included 64 completely resected patients. Twenty patients (31%) had visceral disease. With a median follow-up of 5 years, the median relapse-free survival was 5 months (95% CI, 3-7 months) whereas median overall survival was 21 months (95% CI, 16-34 months). Overall survivals at 3 and 4 years were 36% and 31%, respectively. CONCLUSIONS: In a prospective multicenter setting, appropriately selected patients with stage IV melanoma achieved prolonged overall survival after complete surgical resection. Although median relapse-free survival was only 5 months, patients could still frequently undergo subsequent surgery for isolated recurrences. This patient population is appropriate for aggressive surgical therapy and for trials evaluating adjuvant therapy. Cancer 2011;. © 2011 American Cancer Society. One of the only prospective analyses of surgery for metastatic disease in patients with stage IV disease, this article reports on a multicenter cooperative group trial with enrollment of patients from 18 different institutions. Incorporating consistent monitoring is a hallmark of cooperative group trials. Copyright © 2011 American Cancer Society.

Von Mehren M.,Chase Medical | Rankin C.,Southwest Oncology Group | Goldblum J.R.,Cleveland Clinic | Demetri G.D.,Dana-Farber Cancer Institute | And 5 more authors.
Cancer | Year: 2012

BACKGROUND: Patients with advanced soft tissue sarcomas (STS) have limited therapeutic options. Sorafenib (BAY 43-9006) is a multitargeted tyrosine kinase inhibitor of raf, vascular endothelial growth factor receptors 1 (VEGFR1) through 3, platelet-derived growth factor B, fms-like tyrosine kinase 3, and c-kit, and some of these may be relevant in STS. METHODS: The authors tested sorafenib at a dose of 400 mg twice daily in patients with advanced vascular sarcoma (VS), high-grade liposarcomas, and leiomyosarcomas who had received 0 or 1 previous regimens for advanced disease. RESULTS: Fifty-one patients were accrued to the study, and 37 were evaluable for toxicity and response. There were no unexpected side effects and no confirmed responses. The median progression-free survival was 3 months, and the median overall survival was 17 months. Six of 8 patients in the VS cohort had prolonged clinical benefit (stable disease or better), resulting in a median progression-free survival of 5 months compared with 2 to 3 months for the patients who had liposarcoma and leiomyosarcomas. CONCLUSIONS: Sorafenib at the dose and schedule studied did not result in any responses in the VS, liposarcoma, or leiomyosarcoma cohort according to Response Evaluation Criteria in Solid Tumors. © 2011 American Cancer Society.

Ludwig H.,Center for Oncology and Hematology | Durie B.G.M.,Southwest Oncology Group | McCarthy P.,Roswell Park Cancer Institute | Palumbo A.,University of Turin | And 23 more authors.
Blood | Year: 2012

Maintaining results of successful induction therapy is an important goal in multiple myeloma. Here, members of the International Myeloma Working Group review the relevant data. Thalidomide maintenance therapy after autologous stem cell transplantation improved the quality of response and increased progression-free survival (PFS) significantly in all 6 studies and overall survival (OS) in 3 of them. In elderly patients, 2 trials showed a significant prolongation of PFS, but no improvement in OS. A meta-analysis revealed a significant risk reduction for PFS/eventfree survival and death. The role of thalidomide maintenance after melphalan, prednisone, and thalidomide is not well established. Two trials with lenalidomide maintenance treatment after autologous stem cell transplantation and one study after conventional melphalan, prednisone, and lenalidomide induction therapy showed a significant risk reduction for PFS and an increase in OS in one of the transplant trials. Maintenance therapy with single-agent bortezomib or in combination with thalidomide or prednisone has been studied. One trial revealed a significantly increased OS with a bortezomib-based induction and bortezomib maintenance therapy compared with conventional induction and thalidomide maintenance treatment. Maintenance treatment can be associated with significant side effects, and none of the drugs evaluated is approved for maintenance therapy. Treatment decisions for individual patients must balance potential benefits and risks carefully, as a widely agreed-on standard is not established.

Powell B.L.,Cancer and Leukemia Group B | Moser B.,Cancer and Leukemia Group B | Stock W.,Cancer and Leukemia Group B | Gallagher R.E.,Eastern Cooperative Oncology Group | And 10 more authors.
Blood | Year: 2010

Arsenic trioxide (As2O3) is a highly effective treatment for patients with relapsed acute promyelocytic leukemia (APL); its role as consolidation treatment for patients in first remission has not been defined. We randomized 481 patients (age ≥ 15 years) with untreated APL to either a standard induction regimen of tretinoin, cytarabine, and daunorubicin, followed by 2 courses of consolidation therapy with tretinoin plus daunorubicin, or to the same induction and consolidation regimen plus two 25-day courses of As2O3 consolidation immediately after induction. After consolidation, patients were randomly assigned to one year of maintenance therapy with either tretinoin alone or in combination with methotrexate and mercaptopurine. Ninety percent of patients on each arm achieved remission and were eligible to receive their assigned consolidation therapy. Event-free survival, the primary end point, was significantly better for patients assigned to receive As2O3 consolidation, 80% compared with 63% at 3 years (stratified logrank test, P < .0001). Survival, a secondary end point, was better in the As2O3 arm, 86% compared with 81% at 3 years (P = .059). Disease-free survival, a secondary end point, was significantly better in the As2O3 arm, 90% compared with 70% at 3 years (P < .0001). The addition of As2O3 consolidation to standard induction and consolidation therapy significantly improves event-free and disease-free survival in adults with newly diagnosed APL. This trial was registered at (NCT00003934). © 2010 by The American Society of Hematology.

PubMed | Southwest Oncology Group
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016

6513 Background: Although adults with AML containing CBF translocations [t(8;21) or inv(16)/t(16;16)] have a high complete response (CR) rate and improved overall survival (OS) compared to other AML patients (pts), not everyone does well.In order to better understand the spectrum of CBF-associated AML, we analyzed 373 pts with newly diagnosed CBF-related AML treated on SWOG, ECOG or MDA protocols.Pts ranged in age from 16-83 (median 39) with a slight male predominance (56%). Overall, 53% of pts had inv(16) or t(16;16) while 47% had t(8;21); 58% had chromosomal abnormalities in addition to the CBF translocation. Pts with t(8;21) tended to be younger (p=0.03), have lower white counts (p<0.0001) and more often have additional chromosomal abnormalities (p<0.0001). CR was achieved in 86% of pts (95% confidence interval [CI] 82-89%) and the estimated resistant disease (RD) rate was 8% (CI 5-12%). Increasing age was the major factor associated with a decreased CR rate (p=0.0029) and increased incidence of RD (p=0.0014). OS at 10 years was 43% (CI 38-49%), and was significantly lower in older pts (p<0.0001) and those with higher peripheral blast percentage (p=0.0001). Relapse-free survival (RFS) was 40% (CI 34-46%) at 10 years and likewise was associated with age and peripheral blast percent. The treatment results did not differ significantly between pts with t(8:21) versus inv(16) and were not significantly influenced by the presence of additional chromosomal abnormalities.Although pts with CBF-associated AML do relatively well with 43% 10-year OS, considerable improvement is needed, particularly in older patients and those presenting with a higher percent of blasts in their peripheral blood. No significant financial relationships to disclose.

PubMed | Southwest Oncology Group
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016

6014 Background: Analyses of 1993-1996 SWOG therapeutic trials showed adequate accrual of African Americans and women, but substantial underrepresentation of older patients (65).(Hutchins NEJM 1999) We updated these analyses and added Hispanic and Asian/Pacific Islander (Asian/PI) race/ethnicity categories to determine if heightened national awareness and Medicare coverage of clinical trial costs impacted these rates.Female, African American, Hispanic American, Asian/PI and older patient (65) incidence rates were computed for 1997-2000, with additional analysis of age from 2001-July 2002. Corresponding population rates were derived from projected 1998 US Census data and 1997-1998 NCI SEER data. SWOG and SEER rates were compared within 15 different disease sites.14,632 patients were accrued from 1997-2000 (and 5,645 from 2001- July 2002). In the analysis by sex, non-gender-specific diseases (and non-military/VA affiliation) were studied (n=8,450). Overall, female SWOG accrual was 41% compared to 44% in SEER. Adequate representation was also found in African Americans (9.3% v 9.5% SEER), Hispanic Americans(4.1% v 3.8% SEER), and Asian/PIs (2.2% v 1.7% SEER). Patients 65 accounted for 31% of enrollments in SWOG trials (37% in 2001-July 2002), compared to 61% in SEER (prior analysis: 25% SWOG v 63% SEER). Rates for the common cancers are shown in the table.There was adequate representation of women, African Americans, Hispanic Americans, and Asian/PIs in SWOG clinical trials. Older patients continue to be substantially underrepresented, but the overall trend is promising. However, rates in common tumors remain significantly below SEER estimates, except for prostate cancer. These results mandate increased national attention to this issue and prospective study of accrual barriers. [Figure: see text] No significant financial relationships to disclose.

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