Dose escalation study of amrubicin and cisplatin with concurrent thoracic radiotherapy for limited-disease small cell lung cancer View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-09-05

AUTHORS

Midori Shimada, Hiroyuki Yamaguchi, Minoru Fukuda, Hiromi Tomono, Noritaka Honda, Yosuke Dotsu, Hirokazu Taniguchi, Hiroshi Gyotoku, Hiroaki Senju, Shinnosuke Takemoto, Takaya Ikeda, Katsumi Nakatomi, Yoichi Nakamura, Seiji Nagashima, Takuya Yamazaki, Hiroshi Mukae

ABSTRACT

BackgroundAmrubicin and cisplatin is one of the active regimens used to treat patients with extensive-disease (ED)-small cell lung cancer (SCLC), whereas combined therapy involving chemotherapy and concurrent thoracic radiotherapy is the standard treatment for limited-disease (LD)-SCLC.PurposeThis study aimed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of amrubicin and cisplatin with concurrent thoracic radiotherapy (TRT) for LD-SCLC.Patients and methodsPatients that fulfilled the following eligibility criteria were enrolled: being aged ≤ 75 years and chemotherapy-naïve and having a performance status (PS) of 0–1, LD-SCLC, and adequate organ function. The patients received escalating doses of amrubicin on days 1, 2, and 3, and a fixed 60-mg/m2 dose of cisplatin on day 1. Four cycles of chemotherapy were administered, with each cycle lasting 4 weeks. TRT involving 2 Gy/day, once daily, commenced on day 2 of the first cycle of chemotherapy. The initial dose of amrubicin was 20 mg/m2 (level 1), and the dose was escalated to 25 mg/m2 (level 2) and then 30 mg/m2 (level 3).ResultsEight patients from three institutions were enrolled at three dose levels. The patients’ characteristics were as follows: male/female: 3/5; median age (range): 68.5 (60–73); PS 0/1: 4/4; stage IIIA/IIIB disease: 3/5. Both level 3 patients experienced DLT (grade 4 neutropenia and/or leukopenia lasting > 4 days). Level 3 was defined as the MTD, and level 2 was recommended as the dose for this regimen. Seven patients exhibited partial responses, and 1 displayed progressive disease (response rate: 88%). The median progression-free survival and overall survival periods were 11.1 and 39.5 months, respectively. No treatment-related deaths occurred.ConclusionsWhen this regimen was combined with TRT for LD-SCLC, the MTD was 30 mg/m2 for amrubicin and 60 mg/m2 for cisplatin. In addition, neutropenia and leukopenia were DLT, and doses of 25 mg/m2 for amrubicin and 60 mg/m2 for cisplatin are recommended for this regimen. More... »

PAGES

1059-1064

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00280-019-03940-0

DOI

http://dx.doi.org/10.1007/s00280-019-03940-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1120871394

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/31486872


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23 schema:description BackgroundAmrubicin and cisplatin is one of the active regimens used to treat patients with extensive-disease (ED)-small cell lung cancer (SCLC), whereas combined therapy involving chemotherapy and concurrent thoracic radiotherapy is the standard treatment for limited-disease (LD)-SCLC.PurposeThis study aimed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of amrubicin and cisplatin with concurrent thoracic radiotherapy (TRT) for LD-SCLC.Patients and methodsPatients that fulfilled the following eligibility criteria were enrolled: being aged ≤ 75 years and chemotherapy-naïve and having a performance status (PS) of 0–1, LD-SCLC, and adequate organ function. The patients received escalating doses of amrubicin on days 1, 2, and 3, and a fixed 60-mg/m2 dose of cisplatin on day 1. Four cycles of chemotherapy were administered, with each cycle lasting 4 weeks. TRT involving 2 Gy/day, once daily, commenced on day 2 of the first cycle of chemotherapy. The initial dose of amrubicin was 20 mg/m2 (level 1), and the dose was escalated to 25 mg/m2 (level 2) and then 30 mg/m2 (level 3).ResultsEight patients from three institutions were enrolled at three dose levels. The patients’ characteristics were as follows: male/female: 3/5; median age (range): 68.5 (60–73); PS 0/1: 4/4; stage IIIA/IIIB disease: 3/5. Both level 3 patients experienced DLT (grade 4 neutropenia and/or leukopenia lasting > 4 days). Level 3 was defined as the MTD, and level 2 was recommended as the dose for this regimen. Seven patients exhibited partial responses, and 1 displayed progressive disease (response rate: 88%). The median progression-free survival and overall survival periods were 11.1 and 39.5 months, respectively. No treatment-related deaths occurred.ConclusionsWhen this regimen was combined with TRT for LD-SCLC, the MTD was 30 mg/m2 for amrubicin and 60 mg/m2 for cisplatin. In addition, neutropenia and leukopenia were DLT, and doses of 25 mg/m2 for amrubicin and 60 mg/m2 for cisplatin are recommended for this regimen.
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29 schema:keywords ConclusionsWhen
30 DLT
31 Gy/day
32 IIIB disease
33 LD-SCLC
34 MTD
35 MethodsPatients
36 PS 0/1
37 PurposeThis study
38 ResultsEight patients
39 active regimens
40 addition
41 adequate organ function
42 age
43 amrubicin
44 cancer
45 cell lung cancer
46 characteristics
47 chemotherapy
48 chemotherapy-naïve
49 cisplatin
50 concurrent thoracic radiotherapy
51 criteria
52 cycle
53 cycles of chemotherapy
54 day 1
55 day 2
56 days
57 death
58 disease
59 dose
60 dose levels
61 dose-escalation study
62 doses
63 eligibility criteria
64 escalation study
65 females
66 first cycle
67 function
68 initial dose
69 institutions
70 leukopenia
71 level 2
72 level 3
73 level 3 patients
74 levels
75 limited-disease small-cell lung cancer
76 lung cancer
77 m2
78 male/female
79 maximum
80 median age
81 median progression-free survival
82 months
83 neutropenia
84 organ function
85 overall survival period
86 partial response
87 patient characteristics
88 patients
89 performance status
90 period
91 progression-free survival
92 progressive disease
93 radiotherapy
94 regimen
95 regimens
96 response
97 small cell lung cancer
98 stage IIIA/IIIB disease
99 standard treatment
100 status
101 study
102 survival
103 survival period
104 therapy
105 thoracic radiotherapy
106 toxicity
107 toxicity of amrubicin
108 treatment
109 treatment-related deaths
110 weeks
111 years
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