scholarly journals Randomized Phase III Study of Thoracic Radiation in Combination With Paclitaxel and Carboplatin With or Without Thalidomide in Patients With Stage III Non–Small-Cell Lung Cancer: The ECOG 3598 Study

2012 ◽  
Vol 30 (6) ◽  
pp. 616-622 ◽  
Author(s):  
Tien Hoang ◽  
Suzanne E. Dahlberg ◽  
Joan H. Schiller ◽  
Minesh P. Mehta ◽  
Thomas J. Fitzgerald ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Small Cell ◽  
Phase Iii ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Thoracic Radiation ◽  
Grade 3

Purpose The primary objective of this study was to compare the survival of patients with unresectable stage III non–small-cell lung cancer (NSCLC) treated with combined chemoradiotherapy with or without thalidomide. Patients and Methods Patients were randomly assigned to the control arm (PC) involving two cycles of induction paclitaxel 225 mg/m2 and carboplatin area under the curve (AUC) 6 followed by 60 Gy thoracic radiation administered concurrently with weekly paclitaxel 45 mg/m2 and carboplatin AUC 2, or to the experimental arm (TPC), receiving the same treatment in combination with thalidomide at a starting dose of 200 mg daily. The protocol allowed an increase in thalidomide dose up to 1,000 mg daily based on patient tolerability. Results A total of 546 patients were eligible, including 275 in the PC arm and 271 in the TPC arm. Median overall survival, progression-free survival, and overall response rate were 15.3 months, 7.4 months, and 35.0%, respectively, for patients in the PC arm, in comparison with 16.0 months (P = .99), 7.8 months (P = .96), and 38.2% (P = .47), respectively, for patients in the TPC arm. Overall, there was higher incidence of grade 3 toxicities in patients treated with thalidomide. Several grade 3 or higher events were observed more often in the TPC arm, including thromboembolism, fatigue, depressed consciousness, dizziness, sensory neuropathy, tremor, constipation, dyspnea, hypoxia, hypokalemia, rash, and edema. Low-dose aspirin did not reduce the thromboembolic rate. Conclusion The addition of thalidomide to chemoradiotherapy increased toxicities but did not improve survival in patients with locally advanced NSCLC.

scholarly journals Using the Systemic Immune-Inflammation Index (SII) as a Mid-Treatment Marker for Survival among Patients with Stage-III Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

2020 ◽  
Vol 17 (21) ◽  
pp. 7995
Author(s):  
Tithi Biswas ◽  
Kylie H. Kang ◽  
Rohin Gawdi ◽  
David Bajor ◽  
Mitchell Machtay ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Small Cell ◽  
Phase Iii ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Cancer Data ◽  
Immune Inflammation

The Systemic Immune-Inflammation Index (SII) is an important marker of immune function, defined as the product of neutrophil-to-lymphocyte ratio (NLR) and platelet count (P). Higher baseline SII levels have been associated with improved survival in various types of cancers, including lung cancer. Data were obtained from PROCLAIM, a randomized phase III trial comparing two different chemotherapy regimens pemetrexed + cisplatin (PEM) vs. etoposide + cisplatin (ETO), in combination with radiotherapy (RT) for the treatment of stage III non-squamous non-small cell lung cancer (NSCLC). We aimed to determine if SII measured at the mid-treatment window for RT (weeks 3–4) is a significant predictor of survival, and if the effect of PEM vs. ETO differs by quartile (Q) level of SII. Hazard-ratios (HR) for survival were estimated using a proportional hazards model, accounting for the underlying correlated structure of the data. A total of 548 patients were included in our analysis. The median age at baseline was 59 years. Patients were followed for a median of 24 months. Adjusting for age, body mass index, sex, race, and chemotherapy regimen, SII was a significant mid-treatment predictor of both overall (adjusted HR (aHR) = 1.6, p < 0.0001; OS) and progression-free (aHR = 1.3, p = 0.0072; PFS) survival. Among patients with mid-RT SII values above the median (6.8), those receiving PEM (vs. ETO) had superior OS (p = 0.0002) and PFS (p = 0.0002). Our secondary analysis suggests that SII is an informative mid-treatment marker of OS and PFS in locally advanced non-squamous NSCLC.

Radiation pneumonitis in patients with locally advanced non-small cell lung cancer treated with concurrent radiotherapy and gemcitabine after induction with gemcitabine and carboplatin

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e18504-e18504
Author(s):  
R. M. Michel ◽  
D. Gallardo-Rincon ◽  
C. Villarreal-Garza ◽  
A. Astorga-Ramos ◽  
J. Zamora ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Radiation Pneumonitis ◽  
Locally Advanced ◽  
Disease Patient ◽  
Small Cell ◽  
Small Cell Lung ◽  
Thoracic Radiation ◽  
Grade 3

e18504 Background: The combination of chemotherapy (CT) and thoracic radiation (RT) is the standard treatment for locally advanced non-small cell lung cancer (NSCLC). The most favorable CT regime, timing of full-dose CT and the best way to combine CT with RT to maximize systemic and radiosensitizing effects remain to be determined. The aim of this study was to assess the efficacy, safety and tolerability of gemcitabine concurrent with RT after induction CT (gemcitabine + carboplatin) in locally advanced NSCLC. Methods: Patients with histologically proven NSCLC IIIA and IIIB received carboplatin (AUC of 2.5) and gemcitabine (800 mg/m2) on day 1 and 8, every 21 days (two cycles), followed by conventional fractioned RT (60Gy) with concomitant weekly gemcitabine 200 mg/m2 and by consolidation CT. Survival was analyzed with Kaplan-Meier. Results: Median follow-up was of 11.9 months, 11 patients (57.9%) had stage IIIB disease. Patient inclusion was discontinued due to high grade 3/4 radiation pneumonitis events (5/19 patients, 26.3%). One treatment-related death from radiation pneumonitis occurred. The most common hematological side effects grade 3/4 were anemia and neutropenia 3/19 (15.8%) each and thrombocytopenia 4/19 (21.1%) during induction CT. Partial response was observed in 11 patients (57.9%) following induction. After concurrent chemo-radiotherapy, overall response was 68.4%. Four patients underwent surgical resection. Median progression-free survival was 12 ± 1 months (95% CI, 9.8 -14.1). Overall survival was of 21 ± 3.5 months (95% CI, 14–27.9). Conclusions: Concurrent RT with gemcitabine after induction CT with gemcitabine and carboplatin showed a high response rate. However, it is associated with excessive pulmonary toxicity. Adjustments in gemcitabine dosage during RT or changes in RT planning could reduce toxicity. No significant financial relationships to disclose.

PROCLAIM: Randomized Phase III Trial of Pemetrexed-Cisplatin or Etoposide-Cisplatin Plus Thoracic Radiation Therapy Followed by Consolidation Chemotherapy in Locally Advanced Nonsquamous Non–Small-Cell Lung Cancer

2016 ◽  
Vol 34 (9) ◽  
pp. 953-962 ◽  
Author(s):  
Suresh Senan ◽  
Anthony Brade ◽  
Lu-hua Wang ◽  
Johan Vansteenkiste ◽  
Shaker Dakhil ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Radiation Therapy ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Small Cell ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Thoracic Radiation

Purpose The phase III PROCLAIM study evaluated overall survival (OS) of concurrent pemetrexed-cisplatin and thoracic radiation therapy (TRT) followed by consolidation pemetrexed, versus etoposide-cisplatin and TRT followed by nonpemetrexed doublet consolidation therapy. Patients and Methods Patients with stage IIIA/B unresectable nonsquamous non–small-cell lung cancer randomly received (1:1) pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 intravenously every 3 weeks for three cycles plus concurrent TRT (60 to 66 Gy) followed by pemetrexed consolidation every 3 weeks for four cycles (arm A), or standard therapy with etoposide 50 mg/m2 and cisplatin 50 mg/m2 intravenously, every 4 weeks for two cycles plus concurrent TRT (60 to 66 Gy) followed by two cycles of consolidation platinum-based doublet chemotherapy (arm B). The primary objective was OS. The study was designed as a superiority trial with 80% power to detect an OS hazard ratio of 0.74 with a type 1 error of .05. Results Enrollment was stopped early because of futility. Five hundred ninety-eight patients were randomly assigned (301 to arm A, 297 to arm B) and 555 patients (283 in arm A, 272 in arm B) were treated. Arm A was not superior to arm B in terms of OS (hazard ratio, 0.98; 95% CI, 0.79 to 1.20; median, 26.8 v 25.0 months; P = .831). Arm A had a significantly lower incidence of any drug-related grade 3 to 4 adverse events (64.0% v 76.8%; P = .001), including neutropenia (24.4% v 44.5%; P < .001), during the overall treatment period. Conclusion Pemetrexed-cisplatin combined with TRT followed by consolidation pemetrexed was not superior to standard chemoradiotherapy for stage III unresectable nonsquamous non–small-cell lung cancer.

Phase III Trial Comparing Docetaxel and Cisplatin Combination Chemotherapy With Mitomycin, Vindesine, and Cisplatin Combination Chemotherapy With Concurrent Thoracic Radiotherapy in Locally Advanced Non–Small-Cell Lung Cancer: OLCSG 0007

2010 ◽  
Vol 28 (20) ◽  
pp. 3299-3306 ◽  
Author(s):  
Yoshihiko Segawa ◽  
Katsuyuki Kiura ◽  
Nagio Takigawa ◽  
Haruhito Kamei ◽  
Shingo Harita ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Combination Chemotherapy ◽  
Locally Advanced ◽  
Small Cell ◽  
Phase Iii ◽  
Thoracic Radiotherapy ◽  
Small Cell Lung ◽  
Grade 3

Purpose To demonstrate the efficacy of docetaxel and cisplatin (DP) chemotherapy with concurrent thoracic radiotherapy (TRT) for patients with locally advanced non–small-cell lung cancer (LA-NSCLC). Patients and Methods Patients age 75 years or younger with LA-NSCLC, stratified by performance status, stage, and institution, were randomly assigned to two arms consisting of DP (docetaxel 40 mg/m2 and cisplatin 40 mg/m2 on days 1, 8, 29, and 36) or mitomycin, vindesine, and cisplatin (MVP) chemotherapy with concurrent TRT. Results Between July 2000 and July 2005, 200 patients were allocated into either the DP or MVP arm. The survival time at 2 years, a primary end point, was favorable to the DP arm (P = .059 by a stratified log-rank test as a planned analysis and P = .044 by an early-period, weighted log-rank as an unplanned analysis). There was a trend toward improved response rate, 2-year survival rate, median progression-free time, and median survival in the DP arm (78.8%, 60.3%,13.4 months, and 26.8 months, respectively) compared with the MVP arm (70.3%, 48.1%, 10.5 months, and 23.7 months, respectively), which was not statistically significant (P > .05). Grade 3 febrile neutropenia occurred more often in the MVP arm than in the DP arm (39% v 22%, respectively; P = .012), and grade 3 to 4 radiation esophagitis was likely to be more common in the DP arm than in the MVP arm (14% v 6%, P = .056). Conclusion DP chemotherapy combined with concurrent TRT is an alternative to MVP chemotherapy for patients with LA-NSCLC.

Current and future therapeutic approaches in locally advanced (stage III) non[ndash ]small cell lung cancer

2002 ◽  
Vol 29 (3 Suppl 12) ◽  
pp. 10-16 ◽  
Author(s):  
Angela Davies ◽  
David R. Gandara ◽  
Primo Lara ◽  
Zelanna Goldberg ◽  
Peter Roberts ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Small Cell ◽  
Stage Iii ◽  
Advanced Stage ◽  
Therapeutic Approaches ◽  
Small Cell Lung
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