S-1-based concomitant chemoradiotherapy for locally advanced non-small cell lung cancer: Two phase I trials from Okayama Lung Cancer Study Group (OLCSG)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7547-7547
Author(s):  
Y. Fujiwara ◽  
K. Kiura ◽  
N. Takigawa ◽  
K. Hotta ◽  
D. Kishino ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Febrile Neutropenia ◽  
Phase I ◽  
Locally Advanced ◽  
Small Cell ◽  
Phase I Trials ◽  
Small Cell Lung ◽  
Two Phase ◽  
Grade 3 ◽  
Experienced Grade

7547 Background: Chemoradiotherapy (CRT) is a standard treatment for unresectable locally advanced non-small cell lung cancer (LA-NSCLC), but the treatment outcomes have remained unsatisfied. Thus, more effective and feasible CRT is urgently needed to improve their survival. S-1 is a newly developed oral 5-fluorouracil derivative and has synergistic effects with radiation. However, the role of S-1 in CRT for LA-NSCLC has been undetermined. Methods: We conducted two phase I trials to define the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of S-1-based chemotherapy when combined with concurrent thoracic radiation (total dose of 60 Gy with 2 Gy per daily fraction) for LA-NSCLC. OLCSG 0501 was designed to evaluate the two cycles of combination of S-1 (days 1–14) and cisplatin (days 1 and 8) for patients aged 75 or younger. S-1/cisplatin dosages (mg/m2) were escalated as follows: 60/30, 60/40, 70/40, 80/40, and 80/50. The other trial, OLCSG 0502, recruited patients aged 76 or older and evaluated S-1 alone. S-1 dosages (mg/m2) were increased as follows: 60, 70, and 80. Results: A total of 44 previously untreated LA-NSCLC patients were enrolled (22 in both trials). The MTDs for S-1/cisplatin and S-1 alone were determined to be 80 mg/m2/day / 50 mg/m2 and 80 mg/m2/day, respectively. In the OLCSG 0501, DLTs included febrile neutropenia, thrombocytopenia, bacterial pneumonia and delayed second cycle of chemotherapy. No patient experienced grade 3 or more acute radiation pneumonitis and only one patient experienced grade 3 radiation esophagitis. In the OLCSG 0502, the DLTs were febrile neutropenia, stomatitis and delayed second cycle of chemotherapy. The overall response rates in OLCSG 0501 and OLCSG 0502 were 86.4% and 59.1%, respectively. Conclusions: These results indicate that S-1-based concomitant CRT would be a feasible treatment option and further phase II trials are currently under way. No significant financial relationships to disclose.

Carboplatin, S-1 and concurrent thoracic radiotherapy for elderly patients with locally advanced non-small cell lung cancer: a multicenter Phase I/II study

2019 ◽  
Vol 49 (7) ◽  
pp. 614-619 ◽  
Author(s):  
Seiji Niho ◽  
Yukio Hosomi ◽  
Hiroaki Okamoto ◽  
Keiji Nihei ◽  
Hiroshi Tanaka ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Elderly Patients ◽  
Phase I ◽  
Phase Ii ◽  
Radiation Pneumonitis ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Small Cell ◽  
Thoracic Radiotherapy ◽  
Small Cell Lung

Abstract Objectives We conducted a Phase I/II study of carboplatin, S-1 and concurrent thoracic radiotherapy (TRT) for elderly patients (71 years or older) with unresectable stage III non-small cell lung cancer (NSCLC). Materials and methods Patients received carboplatin (AUC 3-5) on Day 1 and S-1 (30–40 mg/m2 two times daily) on Days 1–14, every 2 weeks, for up to four cycles, plus concurrent TRT at a total dose of 60 Gy. The primary endpoint for the Phase II study was the 1-year progression-free survival (PFS) rate. Results Eighteen patients were enrolled in the Phase I study. Febrile neutropenia, a decreased platelet count and esophagitis were dose-limiting toxicities. The recommended doses for the Phase II study were determined to be an AUC of 3 for carboplatin, 40 mg/m2 twice daily for S-1. Twenty-eight patients were evaluated in the Phase II study. The 1-year PFS rate was 57.1% (90% CI 41.6–71.4%), and the median PFS was 16.8 months (95% CI 7.8–not assessable [NA]). The lower limit of the 90% CI for 1-year PFS exceeded the prespecified threshold value of 30%; therefore, the primary endpoint was met. Grades 3–4 toxicities included thrombocytopenia (21%) and hyponatremia (11%). Grade 3 radiation pneumonitis was observed in 18% of patients. No treatment-related deaths were observed. Conclusion Combination chemotherapy consisting of carboplatin plus S-1 and concurrent TRT had a promising efficacy in elderly patients with locally advanced NSCLC; however, radiation pneumonitis was frequently observed.

scholarly journals Phase I/II study of docetaxel and cisplatin with concurrent thoracic radiation therapy for locally advanced non-small-cell lung cancer

2003 ◽  
Vol 89 (5) ◽  
pp. 795-802 ◽  
Author(s):  
K Kiura ◽  
◽  
H Ueoka ◽  
Y Segawa ◽  
M Tabata ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Radiation Therapy ◽  
Phase I ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung ◽  
Thoracic Radiation

scholarly journals Phase I study of pemetrexed and concurrent radiotherapy for previously untreated elderly patients with locally advanced non-squamous non-small cell lung cancer

2017 ◽  
Vol 8 (6) ◽  
pp. 577-581 ◽  
Author(s):  
Shinnosuke Takemoto ◽  
Yoichi Nakamura ◽  
Minoru Fukuda ◽  
Hiroaki Senju ◽  
Hiroshi Gyotoku ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Elderly Patients ◽  
Phase I ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Phase I Study ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung ◽  
Concurrent Radiotherapy

Phase I/II study of carboplatin plus nab-paclitaxel and concurrent radiotherapy for patients with locally advanced non–small cell lung cancer

Lung Cancer ◽  
2018 ◽  
Vol 125 ◽  
pp. 136-141 ◽  
Author(s):  
Yuko Kawano ◽  
Tomonari Sasaki ◽  
Hiroyuki Yamaguchi ◽  
Katsuya Hirano ◽  
Atsushi Horiike ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Phase I ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung ◽  
Concurrent Radiotherapy

Phase I study of irinotecan (CPT-11) and cisplatin (CDDP) with concurrent thoracic radiotherapy (TRT) in locally advanced non-small cell lung cancer (NSCLC)

Lung Cancer ◽  
2000 ◽  
Vol 29 (1) ◽  
pp. 72
Author(s):  
Y Nakamura ◽  
M Fukuda ◽  
Mi Fukuda ◽  
H Soda ◽  
M Ichiki ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Phase I ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Phase I Study ◽  
Locally Advanced ◽  
Small Cell ◽  
Thoracic Radiotherapy ◽  
Small Cell Lung

A phase I study of erlotinib in combination with chemoradiation (CRT) for unresectable, locally advanced non-small cell lung cancer (NSCLC)

2005 ◽  
Vol 23 (16_suppl) ◽  
pp. 7113-7113 ◽  
Author(s):  
P. C. Hoffman ◽  
A. M. Mauer ◽  
D. C. Haraf ◽  
E. P. Lester ◽  
L. L. Szeto ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Phase I ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Phase I Study ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung

Phase I trial of escalating doses of ABI-007 (nanoparticle albumin-bound paclitaxel) and gemcitabine in patients (pts) with thoracic malignancies

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18094-18094
Author(s):  
C. B. Lee ◽  
T. E. Stinchcombe ◽  
M. A. Socinski ◽  
D. N. Hayes ◽  
R. M. Goldberg ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Febrile Neutropenia ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Severe Neutropenia ◽  
Hematologic Toxicity ◽  
Small Cell Lung ◽  
Grade 3 ◽  
Thoracic Malignancies

18094 Background: ABI-007, nanoparticle albumin-bound paclitaxel, has a different toxicity profile than solvent-based paclitaxel including a lower rate of severe neutropenia. This trial was designed to determine the maximum tolerated dose (MTD) of ABI-007 in combination with gemcitabine (G) in patients with thoracic malignancies. Methods: Patients were required to have a performance status of 0–1, =3 cytotoxic chemotherapy regimens, and preserved renal, hepatic, and bone marrow function. Patients received G 1,000 mg/m2 on days 1, 8 in all cohorts and ABI-007 on day 1 at doses of 260, 300, 340 mg/m2 depending on the treatment cohort every 21 days (1 cycle = 21 days). Day 8 G dose modifications were: G held for ANC < 500 x 109/L or platelets (plts) < 50,000 x 109/L, and 75% of the G dose was given if the ANC 500–999 x 109/L or plts 50,000–99,000 x 109/L. Dose limiting toxicities (DLT) were assessed after the first cycle and were defined as: grade 3 non-hematologic toxicity, febrile neutropenia, grade 4 anemia or thrombocytopenia, ANC = 500 for = 7 days, 2-week delay in initiating the second cycle, or omission of the day 8 G. Doses were escalated in cohorts of 3–6 pts. Results: Thirteen patients were consented and 12 pts were treated (median age 62.5 years (range 35–75); median number of prior treatments 2.5 (range 1–4); tumor types: 6 non-small cell lung cancer (NSCLC), 5 small cell lung cancer (SCLC), and 1 esophageal. At an ABI-007 dose of 300 mg/m2, 1 of 6 pts experienced a DLT (omission of day 8 G due to ANC < 500), and at an ABI-007 dose of 340 mg/m2 2 of 3 patients experienced a DLT (1 pt grade 3 rash and pruritus; 1 pt grade 3 fatigue and anorexia). Additional grade 3 or 4 toxicities observed over all cycles were: neutropenia (n=2), sensory neuropathy (n=1), febrile neutropenia (n=1). G was given at full dose in 38 of the 39 cycles. Eight pts were evaluable for response by RECIST: 4 partial responses (SCLC, n=2; NSCLC, n=2), 4 stable disease (NSCLC, n=3; esophageal, n=1). Conclusions: The MTD of ABI-007 is 300 mg/m2 day 1 in combination with G 1,000 mg/m2 on days 1, 8 every 21 days. This combination was well tolerated and demonstrated activity in previously treated NSCLC and SCLC patients. No significant financial relationships to disclose.

Phase I/II study of amrubicin and nedaplatin in patients with untreated, advanced non-small cell lung cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7569-7569
Author(s):  
Hiroaki Senju ◽  
Daiki Ogawara ◽  
Yoichi Nakamura ◽  
Minoru Fukuda ◽  
Katsumi Nakatomi ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Phase I ◽  
Small Cell Lung Cancer ◽  
Dose Level ◽  
Cell Lung Cancer ◽  
Phase I Study ◽  
Maximum Tolerated Dose ◽  
Small Cell ◽  
Small Cell Lung ◽  
Grade 3

7569 Background: We conducted a phase I/II study of combination chemotherapy with nedaplatin (CDGP) and amrubicin (Amr) for patients with untreated, advanced non small-cell lung cancer (NSCLC). Methods: Eligible patients were having adequate organ function and PS of 0-1. CDGP was given on day 1 and amrubicin on days 1, 2 and 3. The treatment was repeated every 3 weeks. We fixed the dose of CDGP as 100 mg/m2, and escalated the dose of amrubicin from a starting dose of 25 mg/m2 by 5mg/m2 per each levels until the maximum tolerated dose (MTD). The MTD was defined as the dose level at which at least two of three or two of six patients experienced a dose-limiting toxicity (DLT). Results: Between June 2009 and May 2011, 36 patients were enrolled. In the phase I study, two DLTs occurred in six patients at level 2; dose level 1 was therefore recommended (25 mg/m2 Amr, 100mg/m2 CDGP). DLTs included cerebral infarction and grade 4 thrombocytopenia. In the phase II study, including phase I study, a total of 36 patients were enrolled and 132 cycles of chemotherapy were conducted. Grade 3 or 4 neutropenia, grade 3 anemia and grade 3 or 4 thrombocytopenia occurred in 75%, 16.6% and 19.4% in all cycles, respectively. Febrile neutropenia occurred in 4cycles (3%) but all of them were controllable. Eighteen patients achieved a partial response and the overall response rate was 51.4%. Conclusions: Combination of CDGP and Amr was highly effective and well tolerable in patients with untreated, advanced NSCLC.

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