Phase II study of concurrent radiotherapy and chemotherapy for unresectable stage III non-small-cell lung cancer. Southern Osaka Lung Cancer Study Group.

1995 ◽  
Vol 13 (4) ◽  
pp. 869-875 ◽  
Author(s):  
K Furuse ◽  
K Kubota ◽  
M Kawahara ◽  
N Kodama ◽  
M Ogawara ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Survival Rate ◽  
Small Cell Lung Cancer ◽  
Small Cell ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Concurrent Radiotherapy ◽  
Unresectable Stage ◽  
Stage Iii Nsclc ◽  
Grade 3

PURPOSE To evaluate the response rate, toxicity, and 2-year survival rate of concurrent radiotherapy and chemotherapy for unresectable stage III non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS Between July 1989 and October 1990, 65 patients with histologically or cytologically proven unresectable stage III NSCLC without T3N0-1M0 disease were entered onto this study. Sixty-one patients were eligible for response, survival, and toxicity analysis. Chemotherapy consisted of vindesine (3 mg/m2 on days 1, 8, 29, and 36), cisplatin (100 mg/m2 on days 1 and 29), and mitomycin (8 mg/m2 on days 1 and 29). Radiotherapy was administered for 3 weeks (2 Gy given 13 times, five fractions per week), followed by 10-day rest periods and then the previous schedule of radiotherapy repeated for 3 weeks. RESULTS Of 61 eligible patients, 53 (86.9%) had a partial response (PR). The median response duration was 39.1 weeks (range, 8.4 to 163+). The median survival time was 16 months and the 2-year survival rate was 36.7%. Of 53 responding patients, 10 (16.4%) are alive and disease-free after 2 years. The major toxicity was leukopenia (> or = grade 3, 95%). Other toxicities of > or = grade 3 included thrombocytopenia (45%), anemia (28%), nausea/vomiting (16%), fever (11%), and esophagitis (6%). Treatment-related death occurred in two patients. One patient died of pulmonary toxicity (interstitial pneumonitis) and the other of esophagobronchial fistula with pulmonary infection. CONCLUSION Concurrent radiotherapy plus chemotherapy with mitomycin, vindesine, and cisplatin (MVP) can be safely administered to patients with stage III NSCLC, with excellent response rates and 2-year survival rates.

Role of T0 status in overall survival for unresectable stage III non-small cell lung cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9026-9026
Author(s):  
Takefumi Komiya ◽  
Emily Powell ◽  
Charles Vu ◽  
Achuta Kumar Guddati
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Survival Rate ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Unresectable Stage ◽  
Stage Iii Nsclc

9026 Background: Occult (T0) primary non-small cell lung cancer (NSCLC) with mediastinal involvement is a known but rare clinical condition. Its prognosis has not been evaluated well in the literature. Methods: Using National Cancer Database (NCDB), cases diagnosed between 2004 and 2016 with unresectable clinical stage III NSCLC with N2 or N3 involvement were selected and assigned to T0 or T1-4 group according to AJCC staging version 6th or 7th. Clinical demographics including use of chemotherapy/immunotherapy in first course of treatment were collected. As validation, independent data using Surveillance, Epidemiology, and End Results Program (SEER) was analyzed accordingly. Survival analyses were conducted using Kaplan-Meier and log-rank tests. Results: A total of 458 and 84,263 cases met criteria for unresectable, N2/N3 stage III NSCLC with T0 and T1-4 status, respectively. T0 status was associated with younger age, recent diagnosis, adenocarcinoma histology, N3, and use of chemotherapy. Overall survival (OS) was improved in T0 over T1-4 group (p < 0.0001) with a five-year survival rate of 30.5% and 12.7%, respectively, with a validation with multivariate proportional hazard models. Propensity score matching analyses using all 458 patients in each group demonstrated a significant difference in OS (p < 0.0001). The difference was also significant in a subset of those who have undergone chemoradiation (p < 0.0001). Independent analysis using SEER data confirmed its superior survival of T0 over T1-4 with a five-year survival rate of 35.3% and 13.5%, respectively. Conclusions: Both NCDB and SEER analyses demonstrated better survival of T0 than T1-4 counterpart in the setting of unresectable stage III NSCLC, irrespective of chemotherapy status. This group may require a distinct assignment to new staging group after further investigation.

scholarly journals Radiotherapy Dose and Induction Chemotherapy Cycles Are Associated With Prognosis and Toxicity Risk: A Retrospective Study of 227 Patients With Unresectable Stage III Non-Small-Cell Lung Cancer

2020 ◽  
Vol 19 ◽  
pp. 153303382095180
Author(s):  
Liyao Chen ◽  
Yu Hou ◽  
Yaoxiong Xia ◽  
Li Chang ◽  
Xianmin Diao ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Prognostic Factors ◽  
Small Cell Lung Cancer ◽  
Induction Chemotherapy ◽  
Small Cell ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Stage Iii Nsclc ◽  
Grade 3 ◽  
Radiotherapy Dose

Objective: Concurrent chemoradiation (cCHRT) has been confirmed as the standard treatment for local advanced non-small-cell lung cancer (NSCLC). This study is to assess the appropriate timing of radiotherapy and cycles of induction chemotherapy for those patients. Methods: 227 inoperable stage III NSCLC patients were selected, we analyzed the potential prognostic factors and the influence of induction chemotherapy was evaluated. Results: The median survival time was 20.7 months; only 25 patients chose chemotherapy alone (11.0%), 137 patients underwent sequential chemoradiation (sCHRT, 60.4%), and 65 patients received cCHRT (28.6%). Multivariate analyses showed radiation therapy (P = 0.001), the Eastern Cooperative Oncology Group (ECOG) score (P = 0.000) and the lymph node stage (P = 0.001) were independent prognostic factors. cCHRT was not found to be superior (P = 0.330). We selected patients received 60-66 Gy and found the cCHRT groups achieved a relatively better outcome, with a median Overall Survival (OS) of 25.2 months vs 20.1 months in the sCHRT group (P = 0.019). We also found cycles of induction chemotherapy did not compromise survival; however, ≥3 cycles resulted in more grade 3-4 hematology toxicities, with a proportion of 18/99 compared with 53/103 among patients who underwent ≤3 cycles. In addition, higher grade hematology toxicities and poor ECOG were also the most common reasons for abandoning cCHRT. Conclusions: For inoperable stage III NSCLC, cCHRT showed its superiority only when the radiotherapy dose was 60-66 Gy. Cycles of induction chemotherapy did not interfere with survival; however, ≥3 cycles resulted in more grade 3-4 hematology toxicities, leading to the cessation of cCHRT.

scholarly journals Long-term survival trends in patients with unresectable stage III non-small cell lung cancer receiving chemotherapy and radiation therapy: a SEER cancer registry analysis

2020 ◽  
Author(s):  
Ryan N Hansen ◽  
Yiduo Zhang ◽  
Brian Seal ◽  
Kellie Ryan ◽  
Candice Yong ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cancer Registry ◽  
Small Cell ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Unresectable Stage ◽  
Stage Iii Nsclc ◽  
Over Time

Abstract Background: To evaluate the value of new therapies for non-small cell lung cancer (NSCLC), it is necessary to understand overall survival (OS) rates associated with previous standard therapies and how these rates have evolved over time. Methods: We retrospectively analyzed data from patients enrolled in the Surveillance, Epidemiology, and End Results (SEER) cancer registry. Adults with unresectable, stage III NSCLC treated with chemoradiotherapy were grouped by diagnosis year (2000–2002; 2003–2005; 2006–2008; 2009–2011; 2012–2013). The primary endpoint was OS (data cut-off, December 31, 2014), estimated using the Kaplan–Meier estimator. Temporal survival-trend significance was tested using a two-sided log-rank trend test. Results: Of 12,865 eligible patients, 59.1% were male, 59.9% had stage IIIB disease, and 62.7% had non-squamous histology. Median age at diagnosis was 67 years. Overall, 10,899 (84.7%) patients died and 1,966 (15.3%) were censored/lost to follow-up. Median follow-up (95% confidence interval [CI]) was 80 (77–82) months; median OS (95% CI) was 15 (15–16) months; 1- and 3-year survival probabilities (95% CI) were 57.7% (56.9–58.6) and 24.1% (23.3–24.8), respectively. Stratification by diagnosis year showed consistent improvements in survival over time ( p < 0.0001 for trend). Median OS was 12, 14, 15, 18, and 19 months in successive cohorts. Conclusions: OS in patients diagnosed with unresectable, stage III NSCLC between 2003 and 2013 was consistent with that from clinical studies of sequential/concurrent chemoradiotherapy. Despite improvement over time, median OS was <2 years and mortality remained high during the first year post-diagnosis.

scholarly journals Understanding clinical practice and survival outcomes in patients with unresectable stage III non-small-cell lung cancer in a single centre in Quebec

2020 ◽  
Vol 27 (5) ◽  
Author(s):  
J. Agulnik ◽  
G. Kasymjanova ◽  
C. Pepe ◽  
M. Hurry ◽  
R.N. Walton ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Tumour Size ◽  
Small Cell ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Unresectable Stage ◽  
Stage Iii Nsclc ◽  
Ecog Ps

Methods A retrospective cohort study considered patients 18 or more years of age diagnosed between January 2007 and May 2018 with unresectable stage iii non-small-cell lung cancer (nsclc) who received combined chemoradiation (crt). Survival was analyzed using the Kaplan–Meier method to determine median overall (os) and progression-free survival (pfs) and the associated 95% confidence intervals (95% cis). Cox regression analysis was performed to identify factors prognostic for survival, including age, sex, smoking status, Eastern Cooperative Oncology Group performance status (ecog ps), histology, treatment type, tumour size, and nodal status. Results Of 226 patients diagnosed with unresectable stage iii disease, 134 (59%) received combined crt. Mean age was 63 years; most patients were white, were current smokers, had an ecog ps of 0 or 1, and had nonsquamous histology. Median pfs was 7.03 months (95% ci: 5.6 months to 8.5 months), and os for the cohort was 18.7 months (95% ci: 12.4 months to 24.8 months). Of those patients, 78% would have been eligible for durvalumab consolidation therapy. Univariate analysis demonstrated a significant os benefit (p = 0.010) for concurrent crt (ccrt) compared with sequential crt (scrt). Disease-specific survival remained significantly better in the ccrt group (p = 0.004). No difference in pfs was found between the ccrt and scrt groups. In addition, tumour size and nodal involvement were significant discriminating factors for survival (p < 0.05). In this patient cohort, 64% of patients progressed and received subsequent therapy. Based on multivariate analysis, tumour size and nodal station were the only factors predictive of survival in patients with unresectable stage iii nsclc treated with crt. Conclusions Combined crt has been the standard treatment for unresectable stage iii nsclc. In our study, a trend of better survival was seen for ccrt compared with scrt. Factors predictive of survival in patients with stage iii disease treated with crt were tumour size and nodal station. Most patients with stage iii disease would potentially be eligible for durvalumab maintenance therapy based on the eligibility criteria from the pacific trial. The use and effectiveness of novel treatments will have to be further studied in our real-world patient population and similar populations elsewhere.

Phase II Study of Twice-Daily High-Dose Thoracic Radiotherapy Alternating With Cisplatin and Vindesine for Unresectable Stage III Non–Small-Cell Lung Cancer: Japan Clinical Oncology Group Study 9306

2002 ◽  
Vol 20 (3) ◽  
pp. 797-803
Author(s):  
Ikuo Sekine ◽  
Yutaka Nishiwaki ◽  
Takashi Ogino ◽  
Akira Yokoyama ◽  
Mari Saito ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Total Dose ◽  
Small Cell ◽  
Stage Iii ◽  
High Dose ◽  
Thoracic Radiotherapy ◽  
Small Cell Lung ◽  
Unresectable Stage ◽  
Grade 3

PURPOSE: To evaluate the efficacy and toxicity of high-dose thoracic radiotherapy (TRT) alternating with chemotherapy (CH) for unresectable stage III non–small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Forty-one patients received TRT with 1.5 Gy twice daily, 5 days a week, on weeks 1, 2, 5, 6, and 9, up to a total dose of 66 to 72 Gy, alternating with cisplatin 80 mg/m2 on day 1 and vindesine 3 mg/m2 on days 1 and 8, repeated every 4 weeks, for two or three courses beginning on week 3. RESULTS: The median (range) total dose of TRT and number of CH courses were 72 Gy (16.5 to 72 Gy) and three (zero to three), respectively. Delay in TRT ≥ 5 days was observed in 24 (75%) of 32 patients who completed the projected treatment, due to leukopenia in 12, esophagitis in seven, infection in two, and other causes in three patients. Partial responses were obtained in 36 patients (88%). The median survival time and 3- and 5-year survival rates were 18.4 months, 24%, and 10%, respectively. Grade 3 or 4 leukopenia and esophagitis developed in 32 and seven patients, respectively. Grade 3 or 4 late esophageal toxicity developed in two patients. CONCLUSION: Alternating high-dose TRT and CH for stage III NSCLC produced a high response rate with median and long-term survival comparable to prior trials utilizing standard approaches in this population. Acute and late esophageal toxicity was observed and interruption of TRT was required in most of the patients.

scholarly journals Beyond chemoradiotherapy: improving treatment outcomes for patients with stage III unresectable non-small-cell lung cancer through immuno-oncology and durvalumab (Imfinzi®▼, AstraZeneca UK Limited)

2020 ◽  
Vol 123 (S1) ◽  
pp. 18-27
Author(s):  
Priyanka Patel ◽  
◽  
Doraid Alrifai ◽  
Fiona McDonald ◽  
Martin Forster
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Small Cell ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Unresectable Stage ◽  
Stage Iii Nsclc

AbstractThe treatment paradigm of non-small-cell lung cancer (NSCLC) has rapidly changed in recent years following the introduction of immune-checkpoint inhibition (ICI). Pre-clinically, both chemotherapy and radiotherapy modulate the tumour microenvironment, providing the rationale for clinical trials evaluating their role in combination with immunotherapy. Standard-of-care treatment for patients with unresectable stage III disease is concurrent chemoradiotherapy (cCRT); however, only recently, the combination with ICI has been explored. The Phase 3 PACIFIC study randomised 713 patients with confirmed locally advanced, unresectable, stage III NSCLC, whose disease has not progressed following cCRT, to either the anti-programmed death-ligand 1 (PD-L1) agent durvalumab (Imfinzi®▼, AstraZeneca UK Limited) or placebo. Patients with a PD-L1 status ≥1% treated with durvalumab had a significantly longer median progression-free survival compared with placebo (17.2 vs. 5.6 months, respectively; HR: 0.51; 95% CI: 0.41–0.63), prolonged median overall survival (OS) (NR vs. 28.7 months, respectively; HR: 0.68; 99.73% CI: 0.47–0.997; P = 0.0025) and long-term clinical benefit (3-year OS HR: 0.69; 95% CI: 0.55–0.86). Grade 3 or 4 toxicity was marginally greater in the durvalumab cohort versus placebo (30.5% vs. 26.1%). Based on these results, durvalumab has been licensed in this setting, and further clinical trials are exploring the use of ICI in unresectable stage III NSCLC.

scholarly journals Phase II Study of Cetuximab in Combination With Chemoradiation in Patients With Stage IIIA/B Non–Small-Cell Lung Cancer: RTOG 0324

2011 ◽  
Vol 29 (17) ◽  
pp. 2312-2318 ◽  
Author(s):  
George R. Blumenschein ◽  
Rebecca Paulus ◽  
Walter J. Curran ◽  
Francisco Robert ◽  
Frank Fossella ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Small Cell Lung ◽  
Unresectable Stage ◽  
Stage Iii Nsclc ◽  
Grade 3

Purpose Non–small-cell lung cancer (NSCLC) commonly expresses the epidermal growth factor receptor (EGFR), which is associated with poor clinical outcome. Cetuximab is a chimerized monoclonal antibody that targets the EGFR and, in preclinical models, it demonstrates radiosensitization properties. We report a phase II trial testing the combination of cetuximab with chemoradiotherapy (CRT) in unresectable stage III NSCLC. Patients and Methods Eligibility criteria included unresectable stage III NSCLC, Zubrod performance status ≤ 1, weight loss ≤ 5%, forced expiratory volume in 1 second ≥ 1.2 L, and adequate organ function. Patients received an initial dose of cetuximab (400 mg/m2) on day 1 of week 1 and then weekly doses of cetuximab (250 mg/m2) until completion of therapy (weeks 2 through 17). During week 2, patients started CRT (63 Gy in 35 fractions) with weekly carboplatin at area under the [concentration-time] curve (AUC) 2 and six doses of paclitaxel at 45 mg/m2 followed by carboplatin (AUC 6) and two cycles of paclitaxel (200 mg/m2) during weeks 12 through 17. Primary end points included safety and compliance of concurrent cetuximab and CRT. Results In all, 93 patients were enrolled and 87 were evaluable. Median follow-up was 21.6 months. Response rate was 62% (n = 54), median survival was 22.7 months, and 24-month overall survival was 49.3%. Adverse events related to treatment included 20% grade 4 hematologic toxicities, 8% grade 3 esophagitis, and 7% grade 3 to 4 pneumonitis. There were five grade 5 events. Conclusion The combination of cetuximab with CRT is feasible and shows promising activity. The median and overall survival achieved with this regimen were longer than any previously reported by the Radiation Therapy Oncology Group.

scholarly journals Long-term survival trends in patients with unresectable stage III non-small cell lung cancer receiving chemotherapy and radiation therapy: a SEER cancer registry analysis

2020 ◽  
Author(s):  
Ryan N Hansen ◽  
Yiduo Zhang ◽  
Brian Seal ◽  
Kellie Ryan ◽  
Candice Yong ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cancer Registry ◽  
Small Cell ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Unresectable Stage ◽  
Stage Iii Nsclc ◽  
Over Time

Abstract Background: To evaluate the value of new therapies for non-small cell lung cancer (NSCLC), it is necessary to understand overall survival (OS) rates associated with previous standard therapies and how these rates have evolved over time. Methods: We retrospectively analyzed data from patients enrolled in the Surveillance, Epidemiology, and End Results (SEER) cancer registry. Adults with unresectable, stage III NSCLC treated with chemoradiotherapy were grouped by diagnosis year (2000–2002; 2003–2005; 2006–2008; 2009–2011; 2012–2013). The primary endpoint was OS (data cut-off, December 31, 2014), estimated using the Kaplan–Meier estimator. Temporal survival-trend significance was tested using a two-sided log-rank trend test. Results: Of 12,865 eligible patients, 59.1% were male, 59.9% had stage IIIB disease, and 62.7% had non-squamous histology. Median age at diagnosis was 67 years. Overall, 10,899 (84.7%) patients died and 1,966 (15.3%) were censored/lost to follow-up. Median follow-up (95% confidence interval [CI]) was 80 (77–82) months; median OS (95% CI) was 15 (15–16) months; 1- and 3-year survival probabilities (95% CI) were 57.7% (56.9–58.6) and 24.1% (23.3–24.8), respectively. Stratification by diagnosis year showed consistent improvements in survival over time ( p < 0.0001 for trend). Median OS was 12, 14, 15, 18, and 19 months in successive cohorts. Conclusions: OS in patients diagnosed with unresectable, stage III NSCLC between 2003 and 2013 was consistent with that from clinical studies of sequential/concurrent chemoradiotherapy. Despite improvement over time, median OS was <2 years and mortality remained high during the first year post-diagnosis.

scholarly journals Long-term survival trends in patients with unresectable stage III non-small cell lung cancer receiving chemotherapy and radiation therapy: a SEER cancer registry analysis

2020 ◽  
Author(s):  
Ryan N Hansen ◽  
Yiduo Zhang ◽  
Brian Seal ◽  
Kellie Ryan ◽  
Candice Yong ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cancer Registry ◽  
Small Cell ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Unresectable Stage ◽  
Stage Iii Nsclc ◽  
Over Time

Abstract Background: To evaluate the value of new therapies for non-small cell lung cancer (NSCLC), it is necessary to understand overall survival (OS) rates associated with previous standard therapies and how these rates have evolved over time. Methods: We retrospectively analyzed data from patients enrolled in the Surveillance, Epidemiology, and End Results (SEER) cancer registry. Adults with unresectable, stage III NSCLC treated with chemoradiotherapy were grouped by diagnosis year (2000–2002; 2003–2005; 2006–2008; 2009–2011; 2012–2013). The primary endpoint was OS (data cut-off, December 31, 2014), estimated using the Kaplan–Meier estimator. Temporal survival-trend significance was tested using a two-sided log-rank trend test. Results: Of 12,865 eligible patients, 59.1% were male, 59.9% had stage IIIB disease, and 62.7% had non-squamous histology. Median age at diagnosis was 67 years. Overall, 10,899 (84.7%) patients died and 1,966 (15.3%) were censored/lost to follow-up. Median follow-up (95% confidence interval [CI]) was 80 (77–82) months; median OS (95% CI) was 15 (15–16) months; 1- and 3-year survival probabilities (95% CI) were 57.7% (56.9–58.6) and 24.1% (23.3–24.8), respectively. Stratification by diagnosis year showed consistent improvements in survival over time ( p < 0.0001 for trend). Median OS was 12, 14, 15, 18, and 19 months in successive cohorts. Conclusions: OS in patients diagnosed with unresectable, stage III NSCLC between 2003 and 2013 was consistent with that from clinical studies of sequential/concurrent chemoradiotherapy. Despite improvement over time, median OS was <2 years and mortality remained high during the first year post-diagnosis.

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