-
[show abstract]
[hide abstract]
ABSTRACT: The benefit of multimodality therapy is clearly established for adenocarcinomas of the distal esophagus and gastroesophageal junction, but its impact on toxicity is not well defined. We reviewed data from prospective randomized trials to better define the risks of multimodality therapy. The rates of surgical mortality and complications range from 0% to 10% and 23% to 49%, respectively. Multimodality therapy increases acute toxicity. The rate of severe acute hematologic toxicity varies considerably between trials (3%-78%) and appears to be primarily attributable to chemotherapy. Common severe acute nonhematologic toxicities include esophagitis (16%-63%), infection (2%-30%), pain (3%-24%), and gastrointestinal (6%-60%) and cardiac (3%-19%) events. The individual contribution of each modality to nonhematologic toxicities is unclear, but toxicity is increased when adding radiosensitizing chemotherapy to radiotherapy. There is an acute decrease in quality of life with multimodality therapy; however, quality of life usually returns to, or exceeds, baseline by 12 months after therapy. Late toxicities are less well defined, but commonly include esophageal, pulmonary, and cardiac toxicities.
Seminars in radiation oncology 01/2013; 23(1):60-73. · 4.32 Impact Factor
-
Mark A Socinski,
Thomas E Stinchcombe,
Dominic T Moore,
Scott N Gettinger,
Roy H Decker,
W Jeffrey Petty, A William Blackstock,
Garry Schwartz,
Scott Lankford,
Amir Khandani,
David E Morris
[show abstract]
[hide abstract]
ABSTRACT: PURPOSEBevacizumab and erlotinib have been shown to improve survival in stage IV non-small-cell lung cancer (NSCLC). This phase I/II trial was designed to incorporate these agents with induction and concurrent chemoradiotherapy in stage III NSCLC. PATIENTS AND METHODS
Patients received induction chemotherapy (carboplatin area under the curve [AUC] 6, paclitaxel 225 mg/m(2), and bevacizumab 15 mg/kg on days 1 and 22) followed by concurrent chemotherapy (carboplatin AUC 2 and paclitaxel 45 mg/m(2) weekly with bevacizumab 10 mg/kg every other week for four doses) and thoracic conformal radiation therapy (TCRT) to 74 Gy. In the phase I portion, cohort 1 received no erlotinib, whereas cohorts 2 and 3 received erlotinib at 100 and 150 mg, respectively, Tuesday through Friday, during TCRT. Consolidation therapy with erlotinib (150 mg daily) and bevacizumab (15 mg/kg every 3 weeks) was planned 3 to 6 weeks later for six cycles.ResultsForty-five eligible patients were enrolled. The objective response rates to induction and overall treatment were 39% (95% CI, 24% to 55%) and 60% (95% CI, 44% to 75%), respectively. The median progression-free and overall survival times were 10.2 months (95% CI, 8.4 to 18.3 months) and 18.4 months (95% CI, 13.4 to 31.7 months), respectively. The principal toxicity was esophagitis (29% grade 3 or 4 esophagitis, with one patient with grade 3 tracheoesophageal fistula), which was often prolonged. Consolidation therapy with bevacizumab and erlotinib was not feasible. CONCLUSION
The use of bevacizumab and erlotinib as administered in this trial is not recommended given the lack of an efficacy signal and the substantial risk of esophageal toxicity.
Journal of Clinical Oncology 10/2012; · 18.37 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: OBJECTIVES:: Gemcitabine is a potent radiosensitizer. When combined with standard radiotherapy (XRT) the gemcitabine dose must be reduced to about 10% of its conventional dose. Oxaliplatin and erlotinib also have radiosensitizing properties. Oxaliplatin and gemcitabine have demonstrated synergy in vitro. We aimed to determine the maximum tolerated dose of oxaliplatin and gemcitabine with concurrent XRT, then oxaliplatin, gemcitaibine, and erlotinib with XRT in the treatment of locally advanced and low-volume metastatic pancreatic or biliary cancer. METHODS:: A modified 3+3 dose-escalation design was used for testing 4 dose levels of oxaliplatin and gemcitabine given once weekly for a maximum of 6 weeks with daily XRT in fractions of 1.8 Gy to a total dose of 50.4 Gy. Dose-limiting toxicity (DLT) was defined as any grade 4 toxicity or grade 3 toxicity resulting in a treatment delay of >1 week. In addition, dose reduction in 2 of the 3 patients in a given cohort was counted as a DLT in dose escalation-deescalation rule in the modified 3+3 design. RESULTS:: Eighteen patients were enrolled, all with pancreatic cancer. Grade 4 transaminitis in a patient in cohort 3 resulted in cohort expansion. Cohort 4, the highest planned dose cohort, had no DLTs. The recommended phase II dose is oxaliplatin 50 mg/m/wk with gemcitabine 200 mg/m/wk and 50.4 Gy XRT. The most prevalent grade 3 toxicities were nausea (22%), elevated transaminases (17%), leucopenia (17%), and hyperglycemia (17%). Median progression-free survival was 7.1 months (95% confidence interval, 4.6-11.1 mo) and median overall survival was 10.8 months (95% confidence interval, 7.1-16.7 mo). The addition of erlotinib was poorly tolerated at the first planned dose level, but full study of the combination was hindered by early closure of the study. CONCLUSIONS:: Weekly oxaliplatin 50 mg/m/wk combined with gemcitabine 200 mg/m/wk and XRT for pancreatic cancer has acceptable toxicity and interesting activity.
American journal of clinical oncology 04/2012; · 2.21 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Conflicting data and substantial controversy exist regarding optimal adjuvant treatment for those patients with resectable or potentially resectable adenocarcinoma of the pancreas. Despite improvements in short-term surgical outcomes, the use of newer chemotherapeutic agents, development of targeted agents and more precise delivery of radiation, the 5-year survival rates for early-stage patients remains less than 25%. This article critically reviews the existing data for various adjuvant treatment approaches for patients with surgically resectable pancreatic cancer. Our review confirms that despite several randomized clinical trials, the optimal adjuvant treatment approach for these patients remains unclear.
Expert Review of Anti-infective Therapy 04/2012; 12(4):469-80. · 2.65 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: 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.
We assessed 14,611 patients (1218 black and 13,393 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.
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.
Black 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.
CancerSpectrum Knowledge Environment 10/2011; 103(20):1498-506. · 14.07 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Patients receiving thoracic radiation often develop pulmonary injury and fibrosis. Currently, there are no effective measures to prevent or treat these conditions. We tested whether blockade of the chemokine, CC chemokine ligand (CCL) 3, and its receptors, CC chemokine receptor (CCR) 1 and CCR5, can prevent radiation-induced lung inflammation and fibrosis. C57BL/6J mice received thoracic radiation, and the interaction of CCL3 with CCR1 or CCR5 was blocked using genetic techniques, or by pharmacologic intervention. Lung inflammation was assessed by histochemical staining of lung tissue and by flow cytometry. Fibrosis was measured by hydroxyproline assays and collagen staining, and lung function was studied by invasive procedures. Irradiated mice lacking CCL3 or its receptor, CCR1, did not develop the lung inflammation, fibrosis, and decline in lung function seen in irradiated wild-type mice. Pharmacologic treatment of wild-type mice with a small molecule inhibitor of CCR1 also prevented lung inflammation and fibrosis. By contrast, mice lacking CCR5 were not protected from radiation-induced injury and fibrosis. The selective interaction of CCL3 with its receptor, CCR1, is critical for radiation-induced lung inflammation and fibrosis, and these conditions can be largely prevented by a small molecule inhibitor of CCR1.
American Journal of Respiratory Cell and Molecular Biology 07/2011; 45(1):127-35. · 5.13 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The purpose of this study was to assess the efficacy and safety of 5-fluorouracil (5FU) and gemcitabine administered concurrently with radiation in patients with locally advanced, nonmetastatic pancreatic cancer.
Eligible patients had histologically confirmed pancreatic adenocarcinoma deemed locally unresectable without evidence of metastatic disease. In addition, all patients underwent laparoscopy or laparotomy before study entry to rule out peritoneal carcinomatosis. Patients received radiation therapy (50.4 Gy) with concurrent infusional 5FU (200 mg/m(2) 5 days/week) and weekly gemcitabine (200 mg/m(2) ). After a 3-week break, patients received weekly gemcitabine at 1000 mg/m(2) for 3 of 4 weeks, for 4 cycles. The primary endpoint of the trial was the proportion of patients surviving 9 months from study entry. Secondary endpoints included objective tumor response, CA19-9 response, overall survival (OS) time to progression (TTP), and toxicity.
Between November 2001 and October 2004, 81 patients were enrolled, 78 of whom were eligible for analysis. With a median follow-up of 55.2 months, the median OS was 12.2 months (95% confidence interval [CI], 10.9-14.9) and the median TTP was 10 months (95% CI, 6.4-12.0). An objective tumor response was seen in 19 patients (25%), and among 56 patients with an elevated CA19-9 at baseline, 29 (52%) had a sustained CA19-9 response. Overall, 41% of patients had grade 3 or greater treatment-related gastrointestinal adverse events.
The combination of 5FU, gemcitabine, and radiation is well tolerated. Survival is comparable with the best results of other recent studies of 5FU and radiation or gemcitabine and radiation.
Cancer 06/2011; 117(12):2620-8. · 4.77 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Cancer and Leukemia Group B (CALGB) 30105 tested two different concurrent chemoradiotherapy platforms with high-dose (74 Gy) three-dimensional conformal radiotherapy (3D-CRT) after two cycles of induction chemotherapy for Stage IIIA/IIIB non-small cell lung cancer (NSCLC) patients to determine if either could achieve a primary endpoint of >18-month median survival. Final results of 30105 demonstrated that induction carboplatin and gemcitabine and concurrent gemcitabine 3D-CRT was not feasible because of treatment-related toxicity. However, induction and concurrent carboplatin/paclitaxel with 74 Gy 3D-CRT had a median survival of 24 months, and is the basis for the experimental arm in CALGB 30610/RTOG 0617/N0628. We conducted a secondary analysis of all patients to determine predictors of treatment-related pulmonary toxicity.
Patient, tumor, and treatment-related variables were analyzed to determine their relation with treatment-related pulmonary toxicity.
Older age, higher N stage, larger planning target volume (PTV)1, smaller total lung volume/PTV1 ratio, larger V20, and larger mean lung dose were associated with increasing pulmonary toxicity on univariate analysis. Multivariate analysis confirmed that V20 and nodal stage as well as treatment with concurrent gemcitabine were associated with treatment-related toxicity. A high-risk group comprising patients with N3 disease and V20 >38% was associated with 80% of Grades 3-5 pulmonary toxicity cases.
Elevated V20 and N3 disease status are important predictors of treatment related pulmonary toxicity in patients treated with high-dose 3D-CRT and concurrent chemotherapy. Further studies may use these metrics in considering patients for these treatments.
International journal of radiation oncology, biology, physics 04/2011; 81(4):e269-74. · 4.59 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: BACKGROUND:: The purpose of this study was to assess the efficacy and safety of 5-fluorouracil (5FU) and gemcitabine administered concurrently with radiation in patients with locally advanced, nonmetastatic pancreatic cancer. METHODS:: Eligible patients had histologically confirmed pancreatic adenocarcinoma deemed locally unresectable without evidence of metastatic disease. In addition, all patients underwent laparoscopy or laparotomy before study entry to rule out peritoneal carcinomatosis. Patients received radiation therapy (50.4 Gy) with concurrent infusional 5FU (200 mg/m(2) 5 days/week) and weekly gemcitabine (200 mg/m(2)). After a 3-week break, patients received weekly gemcitabine at 1000 mg/m(2) for 3 of 4 weeks, for 4 cycles. The primary endpoint of the trial was the proportion of patients surviving 9 months from study entry. Secondary endpoints included objective tumor response, CA19-9 response, overall survival (OS) time to progression (TTP), and toxicity. RESULTS:: Between November 2001 and October 2004, 81 patients were enrolled, 78 of whom were eligible for analysis. With a median follow-up of 55.2 months, the median OS was 12.2 months (95% confidence interval [CI], 10.9-14.9) and the median TTP was 10 months (95% CI, 6.4-12.0). An objective tumor response was seen in 19 patients (25%), and among 56 patients with an elevated CA19-9 at baseline, 29 (52%) had a sustained CA19-9 response. Overall, 41% of patients had grade 3 or greater treatment-related gastrointestinal adverse events. CONCLUSIONS:: The combination of 5FU, gemcitabine, and radiation is well tolerated. Survival is comparable with the best results of other recent studies of 5FU and radiation or gemcitabine and radiation. Cancer 2011;. © 2010 American Cancer Society.
Cancer 12/2010; · 4.77 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: To determine whether [(18)F]fluorodeoxyglucose positron emission tomography (FDG-PET) can delineate patients with esophageal cancer who may not benefit from esophagectomy after chemoradiotherapy.
We reviewed records of 163 patients with histologically confirmed stage I to IVA esophageal cancer receiving chemoradiotherapy with or without resection with curative intent. All patients received surgical evaluation. Initial and postchemoradiotherapy FDG-PET scans and prognostic/treatment variables were analyzed. FDG-PET complete response (PET-CR) after chemoradiotherapy was defined as standardized uptake value ≤ 3.
Eighty-eight patients received trimodality therapy and 75 received chemoradiotherapy. Surgery was deferred primarily due to medical inoperability or unresectable/metastatic disease after chemoradiotherapy. A total of 105 patients were evaluable for postchemoradiotherapy FDG-PET response. Thirty-one percent achieved a PET-CR. PET-CR predicted for improved outcomes for chemoradiotherapy (2-year overall survival, 71% v 11%, P < .01; 2-year freedom from local failure [LFF], 75% v 28%, P < .01), but not trimodality therapy. On multivariate analysis of patients treated with chemoradiotherapy, PET-CR is the strongest independent prognostic variable (survival hazard ratio [HR], 9.82, P < .01; LFF HR, 14.13, P < .01). PET-CR predicted for improved outcomes regardless of histology, although patients with adenocarcinoma achieved a PET-CR less often.
Patients treated with trimodality therapy found no benefit with PET-CR, likely because FDG-PET residual disease was resected. Definitive chemoradiotherapy patients achieving PET-CR had excellent outcomes equivalent to trimodality therapy despite poorer baseline characteristics. Patients who achieve a PET-CR may not benefit from added resection given their excellent outcomes without resection. These results should be validated in a prospective trial of FDG-PET-directed therapy for esophageal cancer.
Journal of Clinical Oncology 09/2010; 28(31):4714-21. · 18.37 Impact Factor
-
Jeffrey A Bogart,
Lydia Hodgson,
Stephen L Seagren, A William Blackstock,
Xiaofei Wang,
Robert Lenox,
Andrew T Turrisi,
John Reilly,
Ajeet Gajra,
Everett E Vokes,
Mark R Green
[show abstract]
[hide abstract]
ABSTRACT: The optimal treatment for medically inoperable stage I non-small-cell lung cancer (NSCLC) has not been defined.
Cancer and Leukemia Group B trial 39904 prospectively assessed accelerated, once-daily, three-dimensional radiotherapy for early-stage NSCLC. The primary objectives were to define the maximally accelerated course of conformal radiotherapy and to describe the short-term and long-term toxicity of therapy. Entry was limited to patients with clinical stage T1N0 or T2N0 NSCLC (< 4 cm) and pulmonary dysfunction. The nominal total radiotherapy dose remained at 70 Gy, while the number of daily fractions in each successive cohort was reduced.
Thirty-nine eligible patients were accrued (eight patients each on cohorts 1 to 4 and seven patients on cohort 5) between January 2001 and July 2005. One grade 3 nonhematologic toxicity was observed in both cohort 3 (dyspnea) and cohort 4 (pain). The major response rate was 77%. After a median follow-up time of 53 months, the actuarial median survival time of all eligible patients was 38.5 months. Local relapse was observed in three patients.
Accelerated conformal radiotherapy was well tolerated in a high-risk population with clinical stage I NSCLC. Outcomes are comparable to prospective reports of alternative therapies, including stereotactic body radiation therapy and limited resection, with less apparent severe toxicity. Further investigation of this approach is warranted.
Journal of Clinical Oncology 11/2009; 28(2):202-6. · 18.37 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: This review identifies evidence that influences current practices in the multidisciplinary treatment and shapes future directions in the treatment of resectable rectal cancer. Recent advances in surgery, radiotherapy and systemic chemotherapy have provided measurable improvements in disease control, functional outcomes and quality of life for patients with rectal cancer. However, controversies remain regarding the optimum delivery of adjuvant therapies. Preoperative radiation either with or without concurrent chemotherapy demonstrates lower recurrence, with minimal survival benefit. Currently, the use of neoadjuvant standard fractionation chemoradiation versus short-course radiation without chemotherapy is controversial and under investigation. New combinations of chemotherapeutic agents and targeted therapies are also being evaluated. In addition, criteria for patient selection are being re-evaluated to determine the relative benefit of modern treatments, so that we may better tailor adjuvant therapy recommendations to be patient-specific. Recommendations for adjuvant treatments of rectal cancer are continuing to evolve; however, survival has been only marginally affected despite low incidence of local recurrence. Future trials should aim to address the role of adjuvant therapies utilizing new criteria, such as function, quality of life and impact on development of metastatic disease.
Expert review of gastroenterology & hepatology 09/2009; 3(4):383-94.
-
Annals of internal medicine 09/2009; 151(8):583-4. · 16.73 Impact Factor
-
Journal of thoracic oncology: official publication of the International Association for the Study of Lung Cancer 08/2009; 4(7):783-4. · 4.55 Impact Factor
-
Journal of Thoracic Oncology 06/2009; 4(7):783-784. · 3.66 Impact Factor
-
The lancet oncology 06/2009; 10(5):435-7. · 14.47 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Chemoradiotherapy (CRT) is commonly employed in the management of esophageal carcinoma-either definitively or as part of a trimodality strategy with includes surgical resection. For patients treated with trimodality therapy, the most optimal sequence of chemoradiation (CRT) in relation to surgical resection is unclear. We reviewed the efficacy, advantages, and disadvantages of preoperative CRT versus postoperative CRT in esophageal cancer patients treated with trimodality therapy. Preoperative chemoradiation enables early treatment of distant metastases while simultaneously treating the primary disease, facilitates definition of radiotherapy target volumes, and may allow resection of advanced disease. It does, however, have considerable toxicity and may reduce the ability of some patients to tolerate resection. Postoperative CRT allows for early debulking, rapidly addresses dysphagia, and allows for CRT based on accurate pathologic staging, but delays systemic treatment. Randomized studies that compare preoperative with postoperative CRT in treating esophageal cancer are needed to identify conclusively the best standard of care. Based on the study information currently available, we conclude that treatment options should be tailored to the individual patient.
Clinical advances in hematology & oncology: H&O 06/2009; 7(5):327-333, 342.
-
Brian E Lally,
Ann M Geiger,
James J Urbanic,
Jerome M Butler,
Stacy Wentworth,
Michael C Perry,
Lynn D Wilson,
Janet K Horton,
Frank C Detterbeck,
Antonius A Miller,
Charles R Thomas, A William Blackstock
[show abstract]
[hide abstract]
ABSTRACT: We used the Surveillance, Epidemiology, and End Results (SEER) database to examine the outcomes of patients with limited stage small cell lung cancer (LS-SCLC) over time and to determine if any trends were present with respect to the publication of significant clinical trials. We assembled a cohort of 6271 patients aged 21 years and older with LS-SCLC diagnosed from 1983 to 1998 and followed through 2005. Potential covariates included patient age at diagnosis, sex, race, year of diagnosis, laterality, tumor size, and location (upper lobe, middle lobe, lower lobe, or main bronchus). In multivariate analysis, older age, male sex, African American race, and main bronchus location were all associated with a statistically significant increase in the mortality hazard. When compared to patients diagnosed in 1983-1987 who did not receive radiotherapy, the hazard for mortality was significantly reduced for patients diagnosed in 1988-1992 regardless of whether they received radiotherapy (HR=0.59; CI 0.52-0.65; p<0.0001) or not (HR=0.67; CI 0.60-0.75; p<0.0001). Patients who were diagnosed in 1993-1998 and received radiotherapy had similarly improved survival (HR=0.53; CI 0.47-0.58; p<0.0001), which was better than patients from the same time era who did not receive radiotherapy (HR=0.77; CI 0.69-0.85; p<0.0001). In conclusion, the survival for patients with LS-SCLC has improved over time. Many factors are likely involved, however we believe that part of this improvement was the result of clinical trials which investigated and subsequently defined chemoradiotherapy as the standard of care. In order to continue to improve clinical outcomes, clinical trials investigating new treatment paradigms are needed.
Lung cancer (Amsterdam, Netherlands) 10/2008; 64(2):226-31. · 3.14 Impact Factor
-
Gastrointestinal cancer research: GCR 10/2008; 2(5):251-2.
-
Mark A Socinski, A William Blackstock,
Jeffrey A Bogart,
Xiaofei Wang,
Michael Munley,
Julian Rosenman,
Lin Gu,
Gregory A Masters,
Peter Ungaro,
Arthur Sleeper,
Mark Green,
Antonius A Miller,
Everett E Vokes
[show abstract]
[hide abstract]
ABSTRACT: To evaluate 74 Gy thoracic radiation therapy (TRT) with induction and concurrent chemotherapy in stage IIIA/B non-small-cell lung cancer (NSCLC).
Patients with stage IIIA/B NSCLC were randomly assigned to induction chemotherapy with either carboplatin (area under the curve [AUC], 6; days 1 and 22) with paclitaxel (225 mg/m(2); days 1 and 22; arm A) or carboplatin (AUC, 5; days 1 and 22) with gemcitabine (1,000 mg/m(2); days 1, 8, 22, and 29; arm B). On day 43, arm A received weekly carboplatin (AUC, 2) and paclitaxel (45 mg/m(2)) while arm B received biweekly gemcitabine (35 mg/m(2)) both delivered concurrently with 74 Gy of TRT utilizing three-dimensional treatment planning. The primary end point was survival at 18 months.
Forty-three and 26 patients were accrued to arms A and B, respectively. Arm B was closed prematurely due to a high rate of grade 4 to 5 pulmonary toxicity. The overall response rate was 66.6% (95% CI, 50.5% to 80.4%) and 69.2% (95% CI, 48.2% to 85.7%) on arm A and B, respectively. The median survival time (MST) and 1-year survival rate was 24.3 months (95% CI, 12.3 to 36.4) and 66.7% (95% CI, 50.3 to 78.7) and 12.5 months (95% CI, 9.4 to 27.6) and 50.0% (95% CI, 29.9 to 67.2) for arms A and B, respectively. The primary toxicities included esophagitis, pulmonary, and fatigue.
Arm A reached the primary end point with an estimated MST longer than 18 months and will be compared with a standard dose of TRT in a planned randomized phase III trial in the United States cooperative groups.
Journal of Clinical Oncology 06/2008; 26(15):2457-63. · 18.37 Impact Factor