A phase III trial to compare atezolizumab (atezo) vs best supportive care (BSC) following adjuvant chemotherapy in patients (pts) with completely resected NSCLC: IMpower010.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS8576-TPS8576 ◽  
Author(s):  
Heather A. Wakelee ◽  
Nasser K. Altorki ◽  
Eric Vallieres ◽  
Caicun Zhou ◽  
Yunxia Zuo ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Tumor Resection ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Disease Stage ◽  
Adjuvant Radiation ◽  
Stage Ib ◽  
Resected Nsclc ◽  
Iiia Nsclc ◽  
To Receive

TPS8576 Background: The anti–PD-L1 mAb atezo blocks the interaction between PD-L1 and its receptors PD-1 and B7.1 and restores anti-tumor immunity. In the OAK trial, pts with 2L/3L advanced NSCLC had improved mOS in the atezo arm (13.8 mo) vs the docetaxel (doc) arm (9.6 mo), with a survival benefit observed regardless of PD-L1 expression levels on tumor cells (TC) or tumor-infiltrating immune cells (IC). However, more effective treatment options are needed for pts with early-stage NSCLC. A global Phase III, randomized, open-label trial, IMpower010 (NCT02486718), is being conducted to evaluate the efficacy and safety of atezo vs BSC following adjuvant cisplatin (cis)–based chemotherapy (chemo) in pts with resected stage IB (tumors ≥ 4 cm)-IIIA NSCLC. Methods: Pts eligible for study must have complete tumor resection 4 to 12 weeks prior to enrollment for pathologic stage IB (tumors ≥ 4 cm)-IIIA NSCLC, be adequately recovered from surgery, be able to receive cis-based adjuvant chemo and have an ECOG PS 0-1. Pts with other malignancies, autoimmune disease, hormonal cancer or radiation therapy within 5 years and prior chemo or immunotherapy are excluded from study. Approximately 1127 pts will be enrolled regardless of PD-L1 status. Pts will receive up to four 21-d cycles of cis-based chemo (cis [75 mg/m2 IV, d 1] + vinorelbine [30 mg/m2 IV, d 1, 8], doc [75 mg/m2 IV, d 1] or gemcitabine [1250 mg/m2 IV, d 1, 8], or pemetrexed [500 mg/m2 IV, d 1; only non-squamous NSCLC]). No adjuvant radiation therapy is permitted. After adjuvant chemo, eligible pts will be randomized 1:1 to receive 16 cycles of atezo 1200 mg q3w or BSC. Stratification factors include sex, histology (squamous vs non-squamous), disease stage (IB vs II vs IIA) and PD-L1 status by IHC (TC2/3 [≥ 5% expressing PD-L1] and any IC vs TC0/1 [ < 5%] and IC2/3 vs TC0/1 and IC0/1 [ < 5%]). The primary endpoint is disease-free survival; secondary endpoints include OS and safety. Exploratory biomarkers, including PD-L1 expression, immune- and tumor-related biomarkers before, during and after treatment with atezo and at radiographic disease recurrence, or confirmation of new primary NSCLC, will be evaluated. Clinical trial information: NCT02486718.

A multicenter, phase III study of carboplatin/paclitaxel versus oral uracil-tegafur as the adjuvant chemotherapy in resected non-small cell lung cancer (NSCLC): Planned interim analyses

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7560-7560 ◽  
Author(s):  
S. Toyooka ◽  
K. Hotta ◽  
H. Nakamura ◽  
M. Nakata ◽  
H. Tada ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Primary Endpoint ◽  
Interim Analysis ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Disease Stage ◽  
Stage Ib ◽  
Resected Nsclc ◽  
Phase Iii Study ◽  
Iiia Nsclc

7560 Background: Recent studies have demonstrated that adjuvant chemotherapy provides a survival benefit in patients with resected NSCLC. In Japan, uracil-tegafur has been recognized as a standard adjuvant strategy for resected NSCLC, however, carboplatin based adjuvant chemotherapy has not been fully evaluated for the treatment of NSCLC patients in an adjuvant setting. The present phase III study assessed the efficacy and safety of carboplatin/paclitaxel and oral uracil-tegafur as the first study to compare intravenous and oral drugs in resected stage IB-IIIA NSCLC. Methods: The patients with pathological stage IB-IIIA NSCLC who underwent complete resection were randomized 1:1 to carboplatin (AUC 5) /paclitaxel (175 mg/m2) every 3 week for 4 cycles (A arm) or uracil-tegafur (250 mg/m2) daily for 2 years (B arm). The primary endpoint was overall survival (OS) and secondary endpoints were disease-free survival and toxicity. The accrual of 200 patients per arm is required to demonstrate an improvement of OS (15% increase) in the A arm compared to B arm. Randomization was stratified by histology and tumor stage. An interim analysis was planned to perform on the first 200 patients recruited and data of survival and toxicity were examined in the first 100 patients. Results: Between November 2004 and November 2008, 200 patients from 31 Japanese centers were randomized and the first 100 patients were included for interim analysis. Median age was 69 (range; 50–80) years. Ninety-eight patients had PS of 0–1 and 2 patients had PS of 2. Sixty-seven patients were male and 23 patients were female. Sixty patients had adenocarcinoma, 30 had squamous cell carcinoma, and 10 had other histologies. Disease stage was IB in 53, IIA in 14, IIB in 19, and IIIA in 14 patients. Toxicities observed during adjuvant chemotherapy were well tolerable. There was no toxic death. The median survival time of A and B arms combined was 4.1 year. Monitoring Committees approved to continue the present study. Conclusions: The present phase III trial with carboplatin/paclitaxel or uracil-tegafur is feasible with manageable toxicity. The study is on course to achieve its primary endpoint. [Table: see text]

Adjuvant Radiation Therapy Increases Disease-Free Survival in Stage IB Merkel Cell Carcinoma

2014 ◽  
Vol 73 (5) ◽  
pp. 531-534 ◽  
Author(s):  
Kevin W. Sexton ◽  
Stephen P. Poteet ◽  
John Bradford Hill ◽  
Alexandra Schmidt ◽  
Ashit Patel ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Cell Carcinoma ◽  
Merkel Cell Carcinoma ◽  
Disease Free Survival ◽  
Adjuvant Radiation ◽  
Merkel Cell ◽  
Free Survival ◽  
Adjuvant Radiation Therapy ◽  
Stage Ib ◽  
Disease Free

Phase III Randomized Trial of Very Accelerated Radiation Therapy Compared With Conventional Radiation Therapy in Squamous Cell Head and Neck Cancer: A GORTEC Trial

2006 ◽  
Vol 24 (18) ◽  
pp. 2873-2878 ◽  
Author(s):  
Jean Bourhis ◽  
Michel Lapeyre ◽  
Jacques Tortochaux ◽  
Michel Rives ◽  
Mehdi Aghili ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Head And Neck ◽  
Squamous Cell ◽  
Disease Free Survival ◽  
Dose Intensity ◽  
Phase Iii ◽  
Locoregional Control ◽  
Free Survival ◽  
Conventional Radiation ◽  
To Receive

Purpose With the aim to increase the dose intensity of radiation therapy (RT), and subsequently the locoregional control rate, a very accelerated RT regimen was compared with conventional RT in a series of patients with head and neck squamous cell carcinoma (HNSCC). Patients and Methods Between 1994 and 1998, 268 patients with T3 or T4, N0 to N3 HNSCC (staged by 1997 International Union Against Cancer criteria) that was not eligible for surgery were randomly assigned to receive either conventional RT, delivering 70 Gy in 7 weeks to the primary tumor and 35 fractions of 2 Gy over 49 days, or to receive very accelerated RT, delivering 62 to 64 Gy in 31 to 32 fractions of 2 Gy over 22 to 23 days (2 Gy/fraction bid). Results The most common tumor site was the oropharynx and most of the patients (70%) had T4 and N1 to N3 tumors in 72% of patients. The main patient and tumor characteristics were well-balanced between the two arms. The median total doses were 63 Gy (accelerated) and 70 Gy (conventional), with a median overall time of 22 days and 48 days, respectively. Acute mucositis was markedly increased in the accelerated-RT arm (P < .001). The locoregional control rate was improved by 24% at 6 years with accelerated RT. In contrast, disease-free survival and overall survival were not significantly different between the two arms. There was no difference in late effects between the two arms. Conclusion The very accelerated RT regimen was feasible and provided a major benefit in locoregional control but had a modest effect on survival.

scholarly journals A phase III study of atezolizumab (atezo) vs placebo as adjuvant therapy in renal cell carcinoma (RCC) patients (pts) at high risk of recurrence following resection (IMmotion010).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS4598-TPS4598 ◽  
Author(s):  
Robert Uzzo ◽  
Axel Bex ◽  
Brian I. Rini ◽  
Laurence Albiges ◽  
Cristina Suarez ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Therapy ◽  
Distant Metastasis ◽  
Single Agent ◽  
Tumor Resection ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Disease Stage ◽  
Free Survival ◽  
Risk Of Recurrence

TPS4598 Background: Nephrectomy is the SOC in early RCC; however, the 5-y relapse rate is 30-40% in stage II or III pts, with tumor stage and grade correlating with survival and recurrence after surgery. Currently, there is a limited role for adjuvant therapy after nephrectomy in pts who have had complete tumor resection; observation is standard. In a Ph II first-line metastatic RCC study, treatment with single-agent atezo (anti–PD-L1) resulted in an ORR of 25%. Thus, IMmotion010, a Ph III, multicenter, randomized, placebo-controlled, double-blinded trial, will evaluate the efficacy and safety of atezo as adjuvant therapy in RCC pts who are at high risk of recurrence after resection (NCT03024996). Methods: Eligible RCC pts (clear cell or sarcomatoid histologies) will have undergone nephrectomy (radical or partial) and be at high risk of recurrence (T2 Grade 4, T3a Grade 3-4, T3b/c any Grade, T4 any Grade or TxN+ any Grade) or have had complete resection of limited metachronous/synchronous metastasis. Pts must show no residual disease or evidence of metastases by CT scan at enrollment. ECOG PS ≤ 1 and tumor specimens evaluable for PD-L1 will also be required. Pts will be randomized 1:1 to receive atezo 1200 mg IV q3w or placebo IV q3w for 16 cycles or 1 y; stratification will be by disease stage (T2/T3a vs T3b/c/T4/N+ vs metastasectomy), region (North America [excluding Mexico] vs rest of world) and PD-L1 status on tumor-infiltrating immune cells (IC; PD-L1 IC expression < 1% vs ≥ 1%). The primary endpoint is independent review facility (IRF)-assessed disease-free survival (DFS), defined as the time from randomization to the first documented recurrence event (local recurrence, new primary RCC, distant metastasis) or death. Secondary endpoints include OS, investigator-assessed DFS, IRF-assessed and investigator-assessed DFS in pts with ≥ 1% PD-L1 IC, disease-specific survival, distant metastasis-free survival and the 3-y rates of IRF-assessed DFS and investigator-assessed DFS. Safety and biomarkers will be evaluated. The planned analysis will occur when at least ≈ 65% of pts in the 2 populations have died. 664 pts will be enrolled at 150-200 sites worldwide. Clinical trial information: NCT03024996.

Cancer Care Ontario and American Society of Clinical Oncology Adjuvant Chemotherapy and Adjuvant Radiation Therapy for Stages I-IIIA Resectable Non–Small-Cell Lung Cancer Guideline

2007 ◽  
Vol 25 (34) ◽  
pp. 5506-5518 ◽  
Author(s):  
Katherine M.W. Pisters ◽  
William K. Evans ◽  
Christopher G. Azzoli ◽  
Mark G. Kris ◽  
Christopher A. Smith ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Radiation ◽  
Small Cell Lung ◽  
Stage Iiia ◽  
Adjuvant Radiation Therapy ◽  
Stage Ib ◽  
Resected Nsclc ◽  
Stage Ia ◽  
American Society

PurposeTo determine the role of adjuvant chemotherapy and radiation therapy in patients with completely resected stage IA-IIIA non–small-cell lung cancer (NSCLC).MethodsThe Cancer Care Ontario Program in Evidence-Based Care and the American Society of Clinical Oncology convened a Joint Expert Panel in August 2006 to review the evidence and draft recommendations for these therapies.ResultsAvailable data support the use of adjuvant cisplatin-based chemotherapy in completely resected NSCLC; however, the strength of the data and consequent recommendations vary by disease stage. Adjuvant radiation therapy appears detrimental to survival in stages IB and II, with a possible modest benefit in stage IIIA.ConclusionAdjuvant cisplatin-based chemotherapy is recommended for routine use in patients with stages IIA, IIB, and IIIA disease. Although there has been a statistically significant overall survival benefit seen in several randomized clinical trials (RCTs) enrolling a range of people with completely resected NSCLC, results of subset analyses for patient populations with stage IB disease were not significant, and adjuvant chemotherapy in stage IB disease is not currently recommended for routine use. To date, very few patients with stage IA NSCLC have been enrolled onto RCTs of adjuvant therapy; adjuvant chemotherapy is not recommended in these cases. Evidence from RCTs demonstrates a survival detriment for adjuvant radiotherapy with limited evidence for a reduction in local recurrence. Adjuvant radiation therapy appears detrimental to survival in stage IB and II, and may possibly confer a modest benefit in stage IIIA.

scholarly journals Disparities in Stage at Diagnosis, Treatment, and Survival in Nonelderly Adult Patients With Cancer According to Insurance Status

2014 ◽  
Vol 32 (28) ◽  
pp. 3118-3125 ◽  
Author(s):  
Gary V. Walker ◽  
Stephen R. Grant ◽  
B. Ashleigh Guadagnolo ◽  
Karen E. Hoffman ◽  
Benjamin D. Smith ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Cox Regression ◽  
Insurance Coverage ◽  
Cox Proportional Hazards Model ◽  
Disease Stage ◽  
Insurance Status ◽  
Seer Database ◽  
Poverty Level ◽  
Medicaid Coverage ◽  
To Receive

Purpose The purpose of this study was to determine the association of insurance status with disease stage at presentation, treatment, and survival among the top 10 most deadly cancers using the SEER database. Patients and Methods A total of 473,722 patients age 18 to 64 years who were diagnosed with one of the 10 most deadly cancers in the SEER database from 2007 to 2010 were analyzed. A Cox proportional hazards model was used for multivariable analyses to assess the effect of patient and tumor characteristics on cause-specific death. Results Overall, patients with non-Medicaid insurance were less likely to present with distant disease (16.9%) than those with Medicaid coverage (29.1%) or without insurance coverage (34.7%; P < .001). Patients with non-Medicaid insurance were more likely to receive cancer-directed surgery and/or radiation therapy (79.6%) compared with those with Medicaid coverage (67.9%) or without insurance coverage (62.1%; P < .001). In a Cox regression that adjusted for age, race, sex, marital status, residence, percent of county below federal poverty level, site, stage, and receipt of cancer-directed surgery and/or radiation therapy, patients were more likely to die as a result of their disease if they had Medicaid coverage (hazard ratio [HR], 1.44; 95% CI, 1.41 to 1.47; P < .001) or no insurance (HR, 1.47; 95% CI, 1.42 to 1.51; P < .001) compared with non-Medicaid insurance. Conclusion Among patients with the 10 most deadly cancers, those with Medicaid coverage or without insurance were more likely to present with advanced disease, were less likely to receive cancer-directed surgery and/or radiation therapy, and experienced worse survival.

scholarly journals The Role of Para-Aortic Lymphadenectomy in the Surgical Staging of Women with Intermediate and High-Risk Endometrial Adenocarcinomas

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Taymaa May ◽  
Melina Shoni ◽  
Allison F. Vitonis ◽  
Charles M. Quick ◽  
Whitfield B. Growdon ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Therapy ◽  
Endometrial Adenocarcinoma ◽  
Disease Free Survival ◽  
Disease Recurrence ◽  
Pelvic Lymphadenectomy ◽  
Surgical Staging ◽  
Adjuvant Radiation ◽  
Effective Treatment Option ◽  
To Receive

Objectives. To characterize clinical outcomes in patients with intermediate or high-risk endometrial carcinoma who underwent surgical staging with or without para-aortic lymphadenectomy.Methods. This is a retrospective cohort study of patients with intermediate or high-risk endometrial adenocarcinoma who underwent surgical staging with (PPALN group) or without (PLN) para-aortic lymphadenectomy. Data were collected, Kaplan-Meier curves were generated, and univariate and multivariate analyses performed to compare differences in adjuvant therapy, disease recurrence, disease-free survival (DFS), and overall survival (OS).Results.118 patients were included in the PPALN group and 139 in the PLN group. Patients in the PPALN group were more likely to receive adjuvant vaginal brachytherapy (25.4% versus 11.5%,OR=2.5,P=0.03) and less likely to receive adjuvant multimodal combination therapy (17.81% versus 28.8%,OR=0.28,P=0.002). DFS was improved in the PLN group as compared to PPALN (80% versus 62%,P=0.02). OS was equivalent (P=0.93). Patients in the PPALN group who had less than 10 para-aortic nodes removed were twice as likely to recur than patients who had 10 or more para-aortic nodes or patients in the PLN group (HR 2.08, CI 1.20–3.60,P=0.009).Conclusions. Patients in the PLN group were more likely to receive multimodal adjuvant therapy and had better DFS than the PPALN group. Pelvic lymphadenectomy followed by adjuvant radiation and chemotherapy may represent an effective treatment option for patients with intermediate or high-risk disease. If systematic para-aortic lymphadenectomy is performed and less than 10 para-aortic lymph nodes are obtained, multimodality adjuvant therapy should be considered to improve DFS.

Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31.

1997 ◽  
Vol 15 (3) ◽  
pp. 1013-1021 ◽  
Author(s):  
M V Pilepich ◽  
R Caplan ◽  
R W Byhardt ◽  
C A Lawton ◽  
M J Gallagher ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Radiation Therapy Oncology Group ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Oncology Group ◽  
Phase Iii Trial ◽  
Free Survival ◽  
Carcinoma Of The Prostate ◽  
Androgen Suppression ◽  
Disease Free

PURPOSE Although androgen suppression results in a tumor response/remission in the majority of patients with carcinoma of the prostate, its potential value as an adjuvant has not been substantiated. MATERIALS AND METHODS In 1987, the Radiation Therapy Oncology Group (RTOG) initiated a randomized phase III trial of adjuvant goserelin in definitively irradiated patients with carcinoma of the prostate. A total of 977 patients had been accessioned to the study. Of these, 945 remained analyzable: 477 on the adjuvant arm and 468 on the observation arm. RESULTS Actuarial projections show that at 5 years, 84% of patients on the adjuvant goserelin arm and 71% on the observation arm remain without evidence of local recurrence (P < .0001). The corresponding figures for freedom from distant metastases and disease-free survival are 83% versus 70% (P < .001) and 60% and 44% (P < .0001). If prostate-specific antigen (PSA) level greater than 1.5 ng is included as a failure (after > or = 1 year), the 5-year disease-free survival rate on the adjuvant goserelin arm is 53% versus 20% on the observation arm (P < .0001). The 5-year survival rate (for the entire population) is 75% on the adjuvant arm versus 71% on the observation arm (P = .52). However, in patients with centrally reviewed tumors with a Gleason score of 8 to 10, the difference in actuarial 5-year survival (66% on the adjuvant goserelin arm v 55% on the observation arm) reaches statistical significance (P = .03). CONCLUSION Application of androgen suppression as an adjuvant to definitive radiotherapy has been associated with a highly significant improvement in local control and freedom from disease progression. At this point, with a median follow-up time of 4.5 years, a significant improvement in survival has been observed only in patients with centrally reviewed tumors with a Gleason score of 8 to 10.

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