Phase I study of irinotecan and cisplatin with concurrent split-course radiotherapy in unresectable and locally advanced non-small cell lung cancer

Oka, M.; Fukuda, Minoru; Kinoshita, Akitoshi; Kuba, Mutsuo; Ichiki, Masao; Rikimaru, Toru; Soda, Hiroshi; Takatani, Hiroshi; Narasaki, Fumihiko; Nagashima, Seiji; Nakamura, Yoichi; Hayashi, Nobuyuki; Kohno, Shigeru

doi:10.1016/s0959-8049(01)00099-5

Cited by 11 publications

(12 citation statements)

References 25 publications

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“…When the irinotecan/ cisplatin regimen was used, ordinary concurrent CRT was deemed unacceptable (Yokoyama et al, 1998), and unexpectedly poor results of the sequential CRT in LD-SCLC with a MST of 14.3 Irinotecan and carboplatin in SCLC A Kinoshita et al months and 2-year survival rate of 17.5% (Kudoh et al, 1998) may even suggest unsuitableness of irinotecan/platinum for radiotherapy. To resolve this issue, we administered a split-course early concurrent radiotherapy combined with irinotecan/cisplatin (Oka et al, 2001(Oka et al, , 2002Nagashima et al, 2004). Although the phase II study in LD-SCLC is not finished yet, the MST and 2-year survival rate were 25.2 months and 56.2%, respectively, in our phase I study (Oka et al, 2002).…”

Section: Discussionmentioning

confidence: 97%

Phase II study of irinotecan combined with carboplatin in previously untreated small-cell lung cancer

et al. 2006

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To determine the efficacy and toxicity of irinotecan combined with carboplatin, we conducted a phase II trial. Eligibility criteria were: chemotherapy-naïve, small-cell lung cancer (SCLC), good performance status (PS: 0 -2), agep75 years, and adequate organ function. The patients' characteristics were: male/female ¼ 56/5; PS 0/1/2 ¼ 19/38/4; median age (range) ¼ 68 years(51 -75 years); limited disease (LD)/extensive disease (ED) ¼ 27/34. The patients received irinotecan (50 mg m À2 ) on days 1, 8, and 15, and carboplatin (AUC 5, Chatelut formula) on day 1 every 4 weeks. In total, 61 patients were eligible and all were evaluated. In all, 31 patients were treated with four or more courses of chemotherapy. Of the patients, 17 showed a complete response (CR), 34 showed a partial response (PR), nine had stable disease (SD), and one had progressive disease (PD). The overall response rate was 84% (95% confidence interval (CI), 72 -91%; LD 89%, ED 79%) and the CR rate was 28% (95%CI, 17 -41%; LD 37%, ED 21%). The median time to tumour progression was 6.1 (LD 6.4, ED 5.4) months. The medial survival time was 15.0 (LD 20.0, ED 9.7) months, and the 2-year and 5-year survival rates were 31.1% (LD 48.1%, ED 17.7%) and 9.5% (LD 11.1%, ED 5.9%), respectively. Grade 3 or 4 leucopenia, neutropenia, thrombocytopenia, anaemia, and diarrhoea occurred in 33, 74, 41, 39, and 13% of cases, respectively. In conclusion, the combination of irinotecan and carboplatin is an active and well-tolerated regimen in cases of SCLC.

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Section: Discussionmentioning

confidence: 97%

Phase II study of irinotecan combined with carboplatin in previously untreated small-cell lung cancer

et al. 2006

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“…The doses of the chemotherapy agents were as follows . Small cell lung cancer: (i) irinotecan single agent, 100 mg/m 2 weekly; (ii) irinotecan combined with cisplatin, 60 mg/m 2 on days 1, 8, and 15 and 60 mg/m 2 on day 1 every four weeks, respectively; (iii) irinotecan/cisplatin with concurrent radiotherapy, 40 mg/m 2 on days 1, 8, and 15 and 60 mg/m 2 on day 1 repeated every four weeks, respectively; and (iv) irinotecan combined with carboplatin, 50 mg/m 2 on days 1, 8, and 15 and an area under the curve (AUC) value of 5 on day 1 repeated every four weeks, respectively.…”

Section: Methodsmentioning

confidence: 99%

Relationship between UGT1A127* and UGT1A17* polymorphisms and irinotecan‐related toxicities in patients with lung cancer

et al. 2017

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BackgroundThe objective of this study was to evaluate the effects of gene polymorphisms, including UGT1A1*7, *27, and *29, on the safety of irinotecan therapy.MethodsThe eligibility criteria were: lung cancer patients scheduled to undergo irinotecan therapy, aged ≥ 20 years, with a performance status of 0–2. Thirty‐one patients were enrolled and their blood was collected and used to examine the frequency of UGT1A1*6, *7, *27, *28, and *29 polymorphisms and the concentrations of irinotecan, SN‐38, and SN‐38G after irinotecan therapy.ResultsThe patients’ characteristics were as follows: male/female 25/6, median age 71 years (range 55–84), stage IIB/IIIA/IIIB/IV 2/6/11/12, and adenocarcinoma/squamous cell carcinoma/small cell carcinoma/other 14/10/3/4, respectively. The −/−, *6/−, *7/−, *27/−, *28/−, and *29/− UGT1A1 gene polymorphisms were observed in 10 (32%), 10 (32%), 2 (6%), 2 (6%), 7 (23%), and 0 (0%) cases, respectively. The UGT1A1*27 polymorphism occurred separately from the UGT1A1*28 polymorphism. The lowest leukocyte counts of the patients with the UGT1A1*27 and UGT1A1*6 gene polymorphisms were lower than those observed in the wild‐type patients. SN‐38 tended to remain in the blood for a prolonged period after the infusion of irinotecan in patients with UGT1A1*27 or UGT1A1*28 polymorphisms. No severe myelotoxicity was seen in the patients with UGT1A1*7.Conclusion UGT1A1*27 can occur separately from UGT1A1*28 and is related to leukopenia during irinotecan treatment. UGT1A1*7 is less relevant to irinotecan‐induced toxicities, and UGT1A1*29 seems to have little clinical impact.

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“…The patients who refused experienced grade 3 fatigue, esophagitis, hiccoughs, or grade 4 neutropenia. This problem was discussed by the investigators and irinotecan and cisplatin doses were reduced to 50 and 60 mg/m 2 , respectively, which were nearly 80% of the initial dose, and 3 of 4 patients experienced a partial response at the same dose level in our phase 1 trial 21. After drug‐dose reduction, compliance with the treatment including TRT became favorable and almost all patients completed the treatment, except for 2 patients who experienced pneumonitis and prolonged infection.…”

Section: Resultsmentioning

confidence: 97%

“…Treatment commenced within 1 week of enrollment and 2 cycles of irinotecan/cisplatin therapy were repeated at 4‐week intervals. Based on our phase 1 study,21 patients received 60 mg/m 2 of irinotecan on Days 1, 8, and 15, and 80 mg/m 2 of cisplatin on Day 1. After 16 patients were enrolled the chemotherapy dose was reduced to irinotecan 50 mg/m 2 and cisplatin 60 mg/m 2 .…”

Section: Methodsmentioning

confidence: 99%

“…A previous Japanese trial of irinotecan/cisplatin with concurrent standard radiotherapy of 60 Gy in 30 fractions failed because of unacceptable toxicity 20. In our phase 1 trial,21 we incorporated split‐course radiotherapy with a rest period between 2 chemotherapy cycles and demonstrated tolerability and a good response rate of 69.6% (95% confidence interval [CI], 47.1%–86.8%).…”

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Irinotecan and cisplatin with concurrent split‐course radiotherapy in locally advanced nonsmall‐cell lung cancer

Fukuda

Soda

Fukuda

et al. 2007

Cancer

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The preparation of polyolefin‐based stereoregular diblock copolymers by postpolymerization of ethenyl‐capped syndiotactic polypropylene‐based propylene/norbornene copolymer (sPP‐based P‐N copolymer) led to the successful generation of a structurally uniform stereoregular diblock copolymer for self‐assembly studies. The ethenyl‐capped prepolymer was prepared by conducting propylene/norbornene copolymerization in the presence of Me2C(Cp)(Flu)ZrCl2/MAO. Ozonolysis of ethenyl‐capped sPP‐based P‐N copolymer provided the formyl group end‐capped, end‐functionalized prepolymer with a quantitative functional group conversion ratio. Subsequently, connecting the formyl end‐group of the stereoregular prepolymer by coupling with living anionic polystyrene resulted in the high yield production of stereoregular diblock copolymer (sPP‐based P‐N‐block‐polystyrene), which is difficult to prepare by other methods. The resulting stereoregular diblock copolymer possesses precise chemical architecture to self‐organize into consistent nanostructures as evidenced by transmission electron microscopy and small angle X‐ray scattering. © 2008 Wiley Periodicals, Inc. J Polym Sci Part A: Polym Chem 46: 4843–4856, 2008

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Phase I study of irinotecan and cisplatin with concurrent split-course radiotherapy in unresectable and locally advanced non-small cell lung cancer

Cited by 11 publications

References 25 publications

Phase II study of irinotecan combined with carboplatin in previously untreated small-cell lung cancer

Phase II study of irinotecan combined with carboplatin in previously untreated small-cell lung cancer

Relationship between UGT1A127* and UGT1A17* polymorphisms and irinotecan‐related toxicities in patients with lung cancer

Irinotecan and cisplatin with concurrent split‐course radiotherapy in locally advanced nonsmall‐cell lung cancer

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Phase I study of irinotecan and cisplatin with concurrent split-course radiotherapy in unresectable and locally advanced non-small cell lung cancer

Cited by 11 publications

References 25 publications

Phase II study of irinotecan combined with carboplatin in previously untreated small-cell lung cancer

Phase II study of irinotecan combined with carboplatin in previously untreated small-cell lung cancer

Relationship between UGT1A1*27 and UGT1A1*7 polymorphisms and irinotecan‐related toxicities in patients with lung cancer

Irinotecan and cisplatin with concurrent split‐course radiotherapy in locally advanced nonsmall‐cell lung cancer

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Relationship between UGT1A127* and UGT1A17* polymorphisms and irinotecan‐related toxicities in patients with lung cancer