Study of Paclitaxel, Etoposide, and Cisplatin Chemotherapy Combined With Twice-Daily Thoracic Radiotherapy for Patients With Limited-Stage Small-Cell Lung Cancer: A Radiation Therapy Oncology Group 9609 Phase II Study

2005 ◽  
Vol 23 (22) ◽  
pp. 4991-4998 ◽  
Author(s):  
David S. Ettinger ◽  
Brian A. Berkey ◽  
Ross A. Abrams ◽  
James Fontanesi ◽  
Mitchell Machtay ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Radiation Therapy ◽  
Survival Rate ◽  
Progression Free Survival ◽  
Small Cell ◽  
Thoracic Radiotherapy ◽  
Small Cell Lung ◽  
Free Survival ◽  
Thoracic Radiation ◽  
Grade 3

Purpose To determine the response rate, progression-free survival and overall survival, and toxicity of paclitaxel, etoposide, and cisplatin combined with accelerated hyperfractionated thoracic radiotherapy in patients with limited-disease (LD) small-cell lung cancer (SCLC). Patients and Methods LD-SCLC patients with measurable disease, Karnofsky performance score of ≥ 70, and adequate organ function who were previously untreated were eligible for the study. Treatment was as follows. In cycle 1 of chemotherapy, concurrent thoracic radiation therapy was administered. In cycles 2 to 4, chemotherapy was administered alone. In cycle 1, chemotherapy consisted of paclitaxel 135 mg/m2 intravenous over 3 hours on day 1, etoposide 60 mg/m2 intravenous on day 1 and 80 mg/m2 orally on days 2 and 3, and cisplatin 60 mg/m2 intravenous on day 1. In cycles 2 to 4, the paclitaxel dose was increased to 175 mg/m2, with the etoposide and cisplatin doses remaining the same as in cycle 1. The thoracic radiation therapy consisted of 1.5 Gy in 30 fractions (total dose, 45 Gy) administered 5 days a week for 3 weeks. Results Fifty-five patients were enrolled onto the study, and 53 were assessable. The major toxicities included grade 3 and 4 acute neutropenia (32% and 43%, respectively) and grade 3 and 4 esophagitis (32% and 4%, respectively). Two patients died as a result of therapy (one died of acute respiratory distress syndrome, and one died of sepsis). There was one late fatal pulmonary toxicity. The median survival time was 24.7 months. The 2-year survival rate was 54.7%. The median progression-free survival time was 13 months, with a 2-year progression-free survival rate of 26.4%. Conclusion Although this therapeutic regimen is effective in the treatment of patients with LD-SCLC, it is unlikely that the three-drug combination with thoracic radiation therapy will improve the survival times compared with the etoposide plus cisplatin chemotherapy regimen with thoracic radiation therapy in LD-SCLC patients.

Phase II trial of hyperfractionated accelerated radiation therapy for nonresectable non-small-cell lung cancer: results of Eastern Cooperative Oncology Group 4593.

1998 ◽  
Vol 16 (11) ◽  
pp. 3518-3523 ◽  
Author(s):  
M P Mehta ◽  
S P Tannehill ◽  
S Adak ◽  
L Martin ◽  
D G Petereit ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Radiation Therapy ◽  
Survival Rate ◽  
Response Rate ◽  
Small Cell ◽  
Small Cell Lung ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Grade 3 ◽  
Accelerated Radiation Therapy

PURPOSE To assess the feasibility, toxicity, and efficacy of hyperfractionated accelerated radiation therapy (HART) for non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS Thirty patients from six institutions with stage IIIA or IIIB NSCLC were enrolled between November 1993 and August 1995. Radiation therapy (total dose, 57.6 Gy in 36 fractions) was delivered over 15 days with the use of three daily fractions with a 4-hour interval between fractions and an 8-hour interval between on-cord fields. Patients were not treated on weekends. RESULTS Twenty-eight patients (93%) completed radiation therapy. Treatment-related toxicities of grade 3 or greater included esophagitis in six patients and grade 3 skin reaction in three patients. The overall objective response rate was 54%, and the response rate within the radiation field was 64%. With a minimum follow-up of 19 months in surviving patients, the median survival and 1-year survival rate are 13 months and 57%, respectively. The median relapse-free survival and 1-year relapse-free survival rate are 7 months and 23%, respectively. No transverse myelitis or late toxicities of grade 4 or greater have been observed. CONCLUSION HART, delivered to a total dose of 57.6 Gy over 15 total days, is practical and well tolerated. Survival appears similar to that seen with modern combined modality regimens. A phase III trial is under way.

scholarly journals Impact of previous thoracsic radiation therapy on the efficacy of immune checkpoint inhibitors in advanced non-smasll-cell lung cancer

2020 ◽  
Author(s):  
Shinobu Hosokawa ◽  
Eiki Ichihara ◽  
Akihiro Bessho ◽  
Daijiro Harada ◽  
Koji Inoue ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Radiation Therapy ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Immune Checkpoint ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival ◽  
Thoracic Radiation

Abstract Objectives Studies investigating the association between radiation therapy and the efficacy of immune checkpoint inhibitors in advanced non-small-cell lung cancer have provided inconsistent results, likely due to relatively small cohort sizes. This study investigated the effect of previous thoracic radiation therapy on the efficacy of immune checkpoint inhibitor therapy in a large non-small-cell lung cancer cohort. Patients and methods We conducted a retrospective cohort study using data from 531 non-small-cell lung cancer patients who received monotherapy with programmed cell death protein 1/programmed death-ligand 1 inhibitors at nine institutions. The effects of thoracic radiation therapy on the efficacy of immune checkpoint inhibitors were investigated. Results A total of 531 non-small-cell lung cancer patients treated with immune checkpoint inhibitors were included in this study. The progression-free survival period was significantly longer in patients that had received thoracic radiation therapy before immune checkpoint inhibitor therapy compared to those without previous thoracic radiation therapy (median progression-free survival 5.0 vs. 3.0 months, P = 0.0013). A multivariate analysis showed that thoracic radiation therapy was an independent predictive factor of improved progression-free survival (hazard ratio of progression-free survival: 0.79, P = 0.049). In contrast, extra-thoracic radiation therapy was associated with inferior outcomes (median progression-free survival 3.0 vs. 4.2 months, P = 0.0008). Conclusion Previous thoracic radiation therapy, but not prior extra-thoracic radiation therapy, enhanced the efficacy of anti-programmed cell death protein 1/programmed death-ligand 1 therapy in non-small-cell lung cancer patients.

A phase II study of anlotinib plus whole brain radiation therapy (WBRT) for advanced non-small cell lung cancer with multiple brain metastases.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21063-e21063
Author(s):  
Xiangzhi Zhu ◽  
Hua Tao ◽  
Ming Jiang ◽  
Meiqi Shi ◽  
Cheng Kong ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Radiation Therapy ◽  
Brain Metastases ◽  
Advanced Nsclc ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival ◽  
Multiple Brain Metastases ◽  
Common Grade

e21063 Background: The prognosis of non-small-cell lung cancer (NSCLC) patients(pts) with multiple brain metastases is poor. WBRT is the main treatment for the pts, but QUARTZ study showed that the efficacy of WBRT is unsatisfactory. The synergistic effect of the antiangiogenic therapy with radiation therapy has been well established. Anlotinib, an antiangiogenic multi-target TKI, had significantly improved progression-free survival (PFS) of advanced NSCLC with Brain Metastases. This study aimed to evaluate the efficacy and safety of anlotinib combined with WBRT in pts with brain metastases ( > 3) from advanced NSCLC. Methods: Advanced NSCLC pts with brain metastases ( > 3) who were histologically confirmed to be driver gene wild type or positive and pts who had received two or more previous treatments were eligible. Pts with meningeal metastasis were excluded. All pts were treated with anlotinib (12 mg, QD, day 1 to 14 of a 21-day cycle) combined with WBRT (DT 30Gy/12f), followed by maintenance therapy with anlotinib until disease progression or treatment intolerance. The primary endpoint was intracranial progression-free survival (iPFS). Secondary endpoints were extracranial PFS (ePFS), OS and toxicity. Results: As of 25 Jan 2021, 28 pts were enrolled. The median age was 57.5 years with 46.4% male. 89.3% of pts with adenocarcinoma. 21.4% pts harbored EGFR mutation. A total of 25 pts were included in efficacy analysis. In intracranial evaluation, ORR was 64.0%, DCR was 88.0%, median iPFS was 11.1 months (95% CI 5.9 to 12.1). In extracranial evaluation, ORR was 12.0%, DCR was 84.0%, median ePFS was 6.0months (95% CI 3.2 to 8.8). Most common grade 1-2 adverse events (AEs) were hypertension (67.8%), fatigue (64.2%)，anorexia (46.4%) and hand and foot skin reaction (37.5%). The most common grade 3-4 AEs were hypertension (12.5%), hand and foot skin reaction (10.7%) and fatigue (7.2%). No intracranial hemorrhage occurred during treatment. Dose adjustment due to AE occurred in 21.4% patients. Conclusions: This prospective study shows that the combination of anlotinib and WBRT for patients with multiple brain metastases after standard treatment resistance exhibited an effective therapeutic approach and manageable AEs. For further investigation, large sample and additional clinical trials are warranted. Clinical trial information: ChiCTR1900022093.

Topotecan and etoposide as salvage chemotherapy in patients with irinotecan- and platinum-failed small-cell lung cancer: A phase II study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18177-18177
Author(s):  
H. Choi ◽  
B. Choi ◽  
S. Shin ◽  
S. Cheon ◽  
S. Cheon ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Response Rate ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Grade 3

18177 Background: The efficacy and safety of a combined regimen of topotecan and etoposide was tested in patients with relapsed or refractory small-cell lung cancer. Methods: From October 2003 to May 2005, 23 patients who have failed to the previous irinotecan and platinum chemotherapy received intravenous topotecan 1mg/m2 (day 1–5) followed by intravenous etoposide 80mg/m2 (day 1–3). Treatment was repeated every 21 days for a maximum of 6 cycles. Results: Twelve patients were refractory to first-line chemotherapy. Seventeen patients (73.9%) were male and the median age was 63 years. ECOG performance status was 0–1 in 13 (56.5%) patients. The median cycles of chemotherapy was 3. Twenty one patients were assessable for response evaluation. The overall response rate was 17.4% (0 CR, 4 PR, 7 SD, 10 PD) under the intent-to-treat analysis. After a median follow- up of 20.8 months, median progression free survival was 4.7 months and median overall survival was 9.5 months. The estimated 1-year survival rate was 38.7%. In sensitive relapsed patients, 2 achieved tumor response and median progression free survival and overall survival were 5.5 months and 14.5 months. All patients were assessable for toxicity and major toxicities were myelosuppression. Grade 3/4 neutropenia and thrombocytopenia occurred in 18 (78.3%) and 12 (52.2%) patients, respectively. Grade 3/4 febrile neutropenia occurred in 2 patients (8.7 %) and infection in 3 patients (13.0%). There was one treatment-related death due to pneumonia. Conclusions: This salvage regimen failed to demonstrate a considerable response rate compared with monotherapy for relapsed or refractory SCLC. However, the combination of topotecan and etoposide could be further studied for sensitive relapsed patients pretreated with irinotecan and platinum No significant financial relationships to disclose.

A phase II study of accelerated high-dose thoracic radiation therapy (AHTRT) with concurrent chemotherapy for limited small cell lung cancer: RTOG 0239

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7527-7527
Author(s):  
R. Komaki ◽  
R. Paulus ◽  
D. S. Ettinger ◽  
G. M. Videtic ◽  
J. D. Bradley ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Radiation Therapy ◽  
Survival Rate ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Large Field ◽  
High Dose ◽  
Small Cell Lung ◽  
Thoracic Radiation

7527 Background: Inter-group(IG) study 0096 showed that hyperfractionated and accelerated radiotherapy (HFXART) and concurrent etoposide/cisplatin(EP) improved 5-yr survival (26 %) for patients (pts) with limited small cell lung cancer (LSCLC) compared to daily treatment (TRT) with EP (16%), (p=0.04), HFXART/ EP still had high local failure (LF 40 %) and acute severe esophagitis (ASE) rate (27%). Radiation Therapy Oncology Group (RTOG) 0239 was developed to improve local control (LC) and overall survival (OS) without increasing ASE.Methods: Eligibility included limited stage SCLC, age ≥ 18; P.S. 0–1, with adequate hematologic, hepatic, and renal function. RT was given to large field to 28.8 Gy: 1.8 Gy/ fraction (Fx), 5 days (d) / wk for 16 Fx followed by BID with AP/PA fields in AM @ 1.8 Gy /Fx; boost with 2nd treatment in PM @ 1.8 Gy/Fx on d: 23–26; then off-cord boost, 1.8 Gy, BID, x last 5 days for a total dose of 61.2 Gy in 5 wks. EP was started on day 1 of TRT with P, 60 mg/m2 i.v; E, 120 mg/m2 i.v.; E, 240 mg/m2 p.o. d 2 and 3 or E 120 mg/m2 i.v. / d on d 2 or 3. Repeat cycle every 3 wks x 2 cycles with RT, followed by adjuvant EP alone x 2 cycles. CR pts were asked to participate in the prophylactic cranial irradiation (PCI) study RTOG 0212. RTOG 0239 was designed to detect an improvement in the 2-year survival rate from 47% to 60% with less than 30% of ASE.Results: RTOG 0239 accrued 72 pts (71 eligible) from June 20, 2003 to May 23, 2006. The median follow-up time is 19.0 months for all pts, and 30.4 months for pts still alive. The median age was 63, 52% female, 58% Zubrod PS 0. The 2 -year survival rate was 37 % [95% CI: 25.6, 47.7]. 13 pts (18 %) experienced severe esophagitis. 2 treatment related deaths (2.8%) were reported. Response rates 2 months post RX showed CR 41%, PR 39%, SD 10% and PD 6%. Locoregional control rate at two years was 80%. RT compliance was 95 %.Conclusions: RTOG 0239, AHTRT/EP for LSCLC resulted in 37% 2-year OS, 80% 2 year LC and 18% ASE. Compliance with treatment was high and treatment-related death rate was similar to other chemoradiation regimens. Although 2-year OS did not achieve 60%, excellent LC and low ASE were achieved by RTOG 0239 which became one of 3 arms in an ongoing randomized trial of LSCLC RTOG0538/CALGB30610. [Table: see text]

Phase II Trial of Postoperative Adjuvant Paclitaxel/Carboplatin and Thoracic Radiotherapy in Resected Stage II and IIIA Non–Small-Cell Lung Cancer: Promising Long-Term Results of the Radiation Therapy Oncology Group—RTOG 9705

2005 ◽  
Vol 23 (15) ◽  
pp. 3480-3487 ◽  
Author(s):  
Jeffrey D. Bradley ◽  
Rebecca Paulus ◽  
Mary V. Graham ◽  
David S. Ettinger ◽  
David W. Johnstone ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Small Cell ◽  
Stage Ii ◽  
Oncology Group ◽  
Thoracic Radiotherapy ◽  
Small Cell Lung ◽  
Free Survival

Purpose To determine the overall survival, progression-free survival, and toxicity associated with concurrent paclitaxel/carboplatin and thoracic radiotherapy for completely resected patients with stage II and IIIA non–small-cell lung cancer (NSCLC). Patients and Methods Eighty-eight eligible patients had surgical resection for pathologic stage II or IIIA disease and received postoperative paclitaxel and carboplatin. Concurrent thoracic radiotherapy at 50.4 Gy in 28 fractions for 6 weeks (1.8 Gy/d, 5 days/wk) was given during cycles 1 and 2. A boost of 10.8 Gy in six fractions was given for extracapsular nodal extension or T3 lesions. Results Treatment compliance was acceptable, with 93% compliance for radiation therapy and 86% for chemotherapy completion. The median duration of follow-up was 56.7 months (range, 17 to 61 months). The median overall survival time was 56.3 months, with 1-, 2-, and 3-year survival rates of 86%, 70%, and 61%, respectively. The 1-, 2-, and 3- year progression-free survival rates were 70%, 57%, and 50%, respectively. Brain metastasis occurred as the sole site of first failure in 11%, and 9% failed in other metastatic sites as first failure. Of the 43 patients who died, the cause of death was the treated cancer in 31 (35%). Local failure was a component of first failure in 15% of patients. Toxicities were acceptable. An overall survival comparison to Eastern Cooperative Oncology Group 3590 is favorable. Conclusion The mature results of this trial suggest an improved overall and progression-free survival in this group of resected NSCLC patients, compared with previously reported trials. A phase III trial comparing this treatment regimen with standard therapy seems warranted.

scholarly journals Effects of thoracic radiotherapy timing and duration on progression‐free survival in limited‐stage small cell lung cancer

2018 ◽  
Vol 7 (9) ◽  
pp. 4208-4216 ◽  
Author(s):  
Shen Zhao ◽  
Ting Zhou ◽  
Shuxiang Ma ◽  
Yuanyuan Zhao ◽  
Jianhua Zhan ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Progression Free Survival ◽  
Small Cell ◽  
Thoracic Radiotherapy ◽  
Small Cell Lung ◽  
Free Survival ◽  
Limited Stage

scholarly journals Stereotactic Body Radiation Therapy for Biopsy-Proven Primary Non–Small-Cell Lung Cancer: Experience of Patients With Inoperable Cancer at a Single Brazilian Institution

2018 ◽  
pp. 1-8
Author(s):  
Carlos E.C.V. Abreu ◽  
Fabio Y. Moraes ◽  
Fabiana A. Miranda ◽  
Gabriela S.M. Siqueira ◽  
Rafael Gadia ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Radiation Therapy ◽  
Small Cell Lung Cancer ◽  
Stereotactic Body Radiation Therapy ◽  
Small Cell ◽  
Small Cell Lung ◽  
Free Survival ◽  
Distant Failure ◽  
Primary Nsclc ◽  
Grade 3

Purpose Stereotactic body radiation therapy (SBRT) has emerged as a treatment option for patients with non–small-cell lung cancer (NSCLC). We report the clinical outcomes and toxicity for patients with inoperable primary NSCLC treated with SBRT. Methods Between 2007 and 2015, 102 consecutive lung lesions were treated with SBRT at our center, of which 59 primary NSCLC lesions (from 54 patients with inoperable disease) were retrospectively reviewed (43 lesions were excluded because of metastases or because there was no biopsy specimen). We report infield local control (LC) per SBRT target, regional or distant failure-free survival, and overall survival (OS) per patient, using Kaplan-Meier estimates. Serious toxicity was retrospectively scored using Common Terminology Criteria for Adverse Events, version 4. Results Most of the 54 patients were men (n = 41; 76%), median age was 75 years; stage IA (n = 36; 66%) and adenocarcinoma (n = 43; 80%) were the most common stage and histologic diagnosis, respectively. Five patients had two lung lesions. A median of three fractions (range, 3 to 5 fractions) and a total median dose of 54 Gy (range, 45 to 60 Gy) per lesion were prescribed. The median follow-up was 17.8 months (range, 4 to 56.4 months). The 2-year rates of LC, regional or distant failure-free survival, and OS were 89.1% (95% CI, 72.2% to 96%), 79% (95% CI, 59.8% to 89.8%), and 80% (95% CI, 64% to 89.8%), respectively. Grade 3 to 4 toxicities were observed in two patients (3%): grade 3 pneumonitis (n = 1) and grade 4 skin toxicity (n = 1). Conclusion SBRT results in high rates of 2-year LC, regional or distant failure-free survival, and OS with low rates of severe toxicity in patients with inoperable primary NSCLC disease.

PIT-1: Randomized phase II trail of pemetrexed-cisplatin plus bevacizumab or concurrent thoracic radiation therapy followed by surgery in stage IIIA (N2) nonsquamous non-small cell lung cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9014-9014
Author(s):  
Kazuya Takamochi ◽  
Kenji Suzuki ◽  
Masahiro Tsuboi ◽  
Seiji Niho ◽  
Satoshi Ishikura ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Radiation Therapy ◽  
Induction Therapy ◽  
Surgical Complications ◽  
Small Cell ◽  
Small Cell Lung ◽  
Stage Iiia ◽  
Randomized Phase Ii ◽  
Thoracic Radiation ◽  
Grade 3

9014 Background: PIT-1 (Personized Induction Therapy-1) is a multicenter, open-label, randomized phase II study using selection design of platinum doublet chemotherapy plus angiogenesis inhibitor or concurrent thoracic radiation therapy (TRT) as induction therapy followed by surgery in patients with stage IIIA (N2) nonsquamous non-small cell lung cancer (NSCLC) to investigate the efficacy and safety of these treatment strategies. Methods: Patients with stage IIIA (pathologically proven N2) nonsquamous NSCLC randomly received (1:1) induction therapy consisting of pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) plus bevacizumab (15 mg/kg) intravenously every 3 weeks for three cycles (arm A) or concurrent TRT (45 Gy in 25 fractions) (arm B) followed by surgery. The primary endpoint was 2-year progression-free survival (PFS) rate and key secondary endpoints included overall survival (OS), the objective response rate (ORR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, the pathological complete remission (pCR) rate, feasibility and toxicity. Results: Eighty-eight patients were randomly assigned (each arm, n = 44) between October 2013 and June 2017 and 82 (arm A, n = 42; arm B, n = 40) were treated. Patient demographics were balanced between the two arms. The percentage of patients who received induction therapy followed by surgery was 88.1% (37/42) in arm A and 92.5% (37/40) in arm B. The complete resection rate was 81.1% (30/37) in arm A, and 91.9% (34/37) in arm B. The 2-year PFS rate was 36.8% (95% CI: 22.4-51.2) in arm A, and 50.0% (95% CI: 33.8-64.2) in arm B. The 2-year OS rate was 80.5% (95% CI: 64.7-89.7) in arm A, and 80.0% (95% CI: 64.0-89.5) in arm B. The ORR was 50.0% (21/42) in arm A and 60.0% (24/40) in arm B. The pCR rate was 8.1% (3/37) in arm A and 10.8% (4/37) in arm B. Grade 3 or 4 toxicities occurred during induction therapy in 35.7% of the patients in arm A and 22.5% of the patients in arm B. Grade 3 or 4 surgical complications occurred in 21.4% of the patients in arm A and 20.0% of the patients in arm B. Although no fatal toxicity was observed during induction therapy in either arm, two patients in arm A died after surgery due to bronchopleural fistula. Conclusions: The 2-year PFS rate in arm B was higher than that in arm A. Fatal surgical complications were only observed in arm A. Therefore, we chose pemetrexed-cisplatin plus concurrent thoracic radiation therapy as the investigational induction treatment strategy for a future phase III study. Clinical trial information: 000011941.

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