scholarly journals AURA17 study of osimertinib in Asia-Pacific patients (pts) with EGFR T790M-positive advanced non-small cell lung cancer (NSCLC): Updated phase II results including overall survival (OS)

2018 ◽  
Vol 29 ◽  
pp. ix157 ◽  
Author(s):  
C. Zhou ◽  
M. Wang ◽  
Y. Cheng ◽  
Y. Chen ◽  
Y. Zhao ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Asia Pacific ◽  
Small Cell Lung ◽  
Egfr T790m

Irinotecan, carboplatin and etoposide regimen in extensive disease small cell lung cancer: Phase II trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18153-18153
Author(s):  
K. Syrigos ◽  
N. Katirtzoglou ◽  
A. Charpidou ◽  
T. Botsis ◽  
E. Karapanagiotou ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Small Cell Lung ◽  
Extensive Disease ◽  
Standard Regimen ◽  
Grade Iii

18153 Background: The prognosis for the patients with small cell lung cancer (SCLC) is very poor with metastases often present at the time of diagnosis. Despite the initial chemo-sensitivity the majority of the patients will relapse and die of their disease. Irinotecan, a topoisomerase I inhibitor, has been reported as an active new agent in SCLC. In combination with cisplatin, it has showed superiority in response rates and progression free survival over the standard regimen of cisplatin and etoposide. We conducted a phase II study in order to evaluate the efficacy and safety of Carboplatin, Irinotecan and Etoposide (CIE) combination in extensive-disease SCLC (ED-SCLC) Methods: Forty six chemo-naïve patients with ED-SCLC and PS 0–2 were enrolled. Forty of theme were men and 6 women. All of them were smokers and the median age was 59.6 years. We administered carboplatin AUC 5 on day 1, irinotecan 120 m2 on day 2 and etoposide 75 mg/m2 on days 1, 2, 3 in a 21 days repeated cycles. The treatment was continued for up to 6 cycles. Response assessments were performed after cycles 3 and 6 and every 2 months subsequently. The patients were evaluated for response, survival and toxicity. Clinical (as site of metastasis) and laboratory (such as LDH) parameters were tested as prognostic factors for survival. Results: Two hundred and two cycles were administered with an average of 4.5 cycle per patient. Overall response rate was 52.2% (partial and complete), mean overall survival was 16.3 months (CI: 95%: 13.0–19.7) and there was a 1 year survival rate of 43.47%. Patients with brain metastasis had worse prognosis (P:0.004). The three drug regimen was well tolerated. Only 1 patient had diarrhea grade II, 6 had grade III/IV and 1 patient was referred with abdominal pain. One was presented with fatal thrombocytopenia while two toxic deaths were reported. Nine patients (19.5%) had neutropenia grade III/IV, without being fatal, and 3 were presented with grade III anemia which need blood transfusions. Conclusions: CIE regimen is effective and well tolerated for the treatment of the poor prognosis group of ED-SCLC patients with responses and overall survival comperable to standard regimen (CE). No significant financial relationships to disclose.

NRG Oncology/Alliance LU005: A phase II/III randomized clinical trial of chemoradiation versus chemoradiation plus atezolizumab in limited stage small cell lung cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS9082-TPS9082
Author(s):  
Helen J. Ross ◽  
Chen Hu ◽  
Kristin Ann Higgins ◽  
Salma K. Jabbour ◽  
David E. Kozono ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Small Cell Lung ◽  
Limited Stage ◽  
Thoracic Radiation

TPS9082 Background: Limited stage small cell lung cancer (LS-SCLC) is treated with standard of care platinum/etoposide (EP) and thoracic radiation therapy (TRT) with curative intent, however the majority of patients are not cured and median overall survival is approximately 30 months. Addition of atezolizumab to chemotherapy in extensive stage SCLC has improved progression free and overall survival in a non-curative setting leading to hope that addition of an immune checkpoint inhibitor to standard chemoradiotherapy could benefit LS-SCLC patients. LU005 is a randomized phase II/III trial of standard concurrent chemoradiation with or without atezolizumab for patients with LS-SCLC. Methods: Patients are randomly assigned in a 1:1 ratio to standard EP chemotherapy with concurrent TRT (45 Gy BID or 66 Gy QD) with or without atezolizumab beginning concurrently with TRT, and continued every 3 weeks for up to 12 months. Eligible patients have LS-SCLC, PS 0-2, adequate organ function, no concerning comorbidities (including no active autoimmune disease) and are eligible for TRT. Patients are randomized prior to their second cycle of EP and thoracic radiation begins with the second overall cycle of chemotherapy (first cycle of study therapy) in both treatment arms. Prophylactic cranial radiation (PCI) is recommended for patients who respond to treatment. The phase II/III primary endpoints are progression free (PFS) and overall survival (OS) respectively. Secondary endpoints include objective response rates, local and distant disease control, and quality of life/patient reported outcomes assessment. Translational science component includes blood and tissue based immune related assays. This study activated in May 2019. 50 of 506 planned patients have been accrued as of 2/1/2020. Supported by grants U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), U23CA180803 (IROC) from the National Cancer Institute (NCI) and Genentech. *Authors Ross and Higgins are co-first authors and contributed equally to this work. Clinical trial information: NCT03811002.

Randomized Phase II Trial Comparing Amrubicin With Topotecan in Patients With Previously Treated Small-Cell Lung Cancer: North Japan Lung Cancer Study Group Trial 0402

2008 ◽  
Vol 26 (33) ◽  
pp. 5401-5406 ◽  
Author(s):  
Akira Inoue ◽  
Shunichi Sugawara ◽  
Koichi Yamazaki ◽  
Makoto Maemondo ◽  
Toshiro Suzuki ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Group Performance ◽  
Small Cell ◽  
Small Cell Lung ◽  
Randomized Phase Ii ◽  
Previously Treated

Purpose Amrubicin, a new anthracycline agent, and topotecan are both active for previously treated small-cell lung cancer (SCLC). No comparative study of these agents has been reported. This randomized phase II study was conducted to select amrubicin or topotecan for future evaluation. Patients and Methods Patients with SCLC previously treated with platinum-containing chemotherapy were randomly assigned to receive amrubicin (40 mg/m2 on days 1 through 3) or topotecan (1.0 mg/m2 on days 1 through 5). Patients were stratified by Eastern Cooperative Oncology Group performance status (0, 1, or 2) and type of relapse (chemotherapy sensitive or refractory). The primary end point was overall response rate (ORR), and secondary end points were progression-free survival (PFS), overall survival, and toxicity profile. Results From February 2004 to July 2007, 60 patients were enrolled, and 59 patients (36 patients with sensitive and 23 patients with refractory relapse) were assessable for efficacy and safety evaluation. Neutropenia was severe, and one treatment-related death owing to infection was observed in the amrubicin arm. ORRs were 38% (95% CI, 20% to 56%) for the amrubicin arm and 13% (95% CI, 1% to 25%) for the topotecan arm. In sensitive relapse, ORRs were 53% for the amrubicin arm and 21% for the topotecan arm. In refractory relapse, ORRs were 17% for the amrubicin arm and 0% for the topotecan arm. Median PFS was 3.5 months for patients in the amrubicin arm and 2.2 months for patients in the topotecan arm. Multivariate analysis revealed that amrubicin has more influence than topotecan on overall survival. Conclusion Amrubicin may be superior to topotecan with acceptable toxicity for previously treated patients with SCLC. Further evaluation of amrubicin for relapsed SCLC is warranted.

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.

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