Phase I/II trial of a biweekly combination of S-1 plus docetaxel in patients with previously treated non-small cell lung cancer (KRSG-0601)

Komiyama, Kenichiro; Kobayashi, Kunihiko; Minezaki, Shohei; Kotajima, Futoshi; Sutani, Akihisa; Kasai, Takashi; Mori, Kiyoshi; Hoshi, Eishin; Takayanagi, Noboru; Koyama, Shinichiro; Eguchi, Katsumi; Nakayama, Mitsuo; Kikuchi, Koji

doi:10.1038/bjc.2012.437

Cited by 7 publications

(5 citation statements)

References 36 publications

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“…Approximately 54% of patients present a metastasis at diagnosis due to lack of clinical symptoms at the early stages, which tends to result in an extremely poor prognosis with an overall 5-year survival rate of 3.8% 12. For most advanced lung cancers, standard chemotherapy involving pemetrexed,13,14 oxaliplatin,15 and docetaxel,16 is generally the mainstream of management, but apparently this has reached a plateau with disappointing outcomes 17. Despite the introduction of a series of targeted drugs for patients with epidermal growth factor receptor mutations (gefitinib or erlotinib)18,19 and ALK rearrangement (crizotinib)20 in the past decade, the survival rate still has not been significantly improved.…”

Section: Discussionmentioning

confidence: 99%

Hapten-enhanced therapeutic effect in advanced stages of lung cancer by ultra-minimum incision personalized intratumoral chemoimmunotherapy therapy

Yu¹,

Lu²,

Gao³

et al. 2015

LCTT

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AimThe objective of the study reported here was to evaluate the therapeutic effects of hapten-enhanced chemoimmunotherapy in the treatment of advanced lung cancer by ultra-minimum incision personalized intratumoral chemoimmunotherapy (UMIPIC) and to analyze the effect of this immune booster.Materials and methodsA total of 97 patients with advanced lung cancer were treated with UMIPIC or intratumoral chemotherapy (ITCT). UMIPIC was delivered intratumorally in combination with a proprietary therapeutic regimen composed of three components – an oxidant, a cytotoxic drug, and hapten. ITCT applied using the same procedures and regimen, only without hapten. All data from the two groups were reviewed and analyzed. A total of 55 patients were treated with UMIPIC and 42 with ITCT. Patient responses were assessed with computed tomography scan 4–6 weeks after treatment, and all of the patients were followed until their deaths.ResultsMedian overall survival was 11.23 months in the UMIPIC (test) group and 5.62 months in the ITCT (control) group (P<0.01). The 6-month and 1-year survival rates of the UMIPIC and ITCT groups were 76.36% versus 45.23% (P<0.01) and 45.45% versus 23.81% (P<0.05), respectively. Two cycles of UMIPIC treatment (n=19) conferred a significant survival benefit compared with two cycles of ITCT (n=29); significant benefits in survival time were also found with UMIPIC (n=20) compared with ITCT (n=13) when both were utilized without adjuvant treatment.ConclusionThe hapten-enhanced clinical effect of UMIPIC conferred a superior survival time in patients with advanced lung cancer compared with ITCT. The addition of the hapten in UMIPIC demonstrates a significant advantage in terms of prolonged survival time.

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Section: Discussionmentioning

confidence: 99%

Hapten-enhanced therapeutic effect in advanced stages of lung cancer by ultra-minimum incision personalized intratumoral chemoimmunotherapy therapy

Yu¹,

Lu²,

Gao³

et al. 2015

LCTT

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“…## p<0.01 versus Anti-miRNA-NC group. for surgery (13). In consequence, chemotherapy has become the main treatment method of NSCLC (14).…”

Section: Discussionmentioning

confidence: 99%

miR-141 regulation of EIF4E expression affects docetaxel chemoresistance of non-small cell lung cancer

Wang

et al. 2016

Oncology Reports

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The present study investigated the role of miR-141 regulation of eukaryotic initiation factor-4E (EIF4E) expression in docetaxel chemoresistance of human non-small cell lung cancer (NSCLC). The expression of miR-141 in docetaxel chemoresistant patients with NSCLCs was markedly higher than those of non-docetaxel chemoresistant patients with NSCLCs. The expression of EIF4E in docetaxel chemoresistant patients with NSCLCs was markedly lower than those of non-docetaxel chemoresistant patients with NSCLCs. Downregulation of miR-141 suppressed cell proliferation, induced cell death and increased caspase-3 activity in H1299 or H2009/docetaxel cells. Downregulation of miR-141 also increased the protein expression of EIF4E, VEGF, c-Myc and Bax in H1299 or H2009/docetaxel cells. Conversely, up-regulation of miR-141 promoted cell proliferation, inhibited cell death and caspase-3 activity in H1299 or H2009/docetaxel cell. Upregulation of miR-141 suppressed EIF4E, VEGF, c-Myc protein expression and inhibited Bax in H1299 or H2009/docetaxel cells. Thus, the present study is the first to show the induction of miR-141/EIF4E expression in an acquired model of docetaxel chemoresistant patients with NSCLCs. This serves as a mechanism of acquired docetaxel chemoresistant patients with NSCLCs, possibly through direct interactions with VEGF, c-Myc, and Bax, therefore presenting a potential therapeutic target for the treatment of docetaxel chemoresistant patients with NSCLCs.

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“…Among nonhematologic toxicities, stomatitis and diarrhea tended to be more common compared with the results of other concomitant treatments. This could have been due to S‐1, but the incidence was higher than that reported with S‐1 alone and with DOC + S‐1 combination therapy . Conversely, in a report of a phase II study of S‐1 + PTX in gastric cancer, stomatitis of grade 3 or higher was reported in 28% ; caution should be exercised in interpreting these results as these mucosal lesions may have been increased owing to PTX.…”

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confidence: 85%

Phase II Study of S-1 and Paclitaxel Combination Therapy in Patients with Previously Treated Non-Small Cell Lung Cancer

et al. 2019

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Lessons Learned. In terms of efficacy and safety, good results were obtained with S‐1 and paclitaxel (PTX) combination therapy. The findings suggest that S‐1 and PTX combination therapy is a feasible treatment option in patients with previously treated non‐small cell lung cancer. Background. Although monotherapy with cytotoxic agents, including docetaxel and pemetrexed, is recommended for patients with previously treated advanced non‐small cell lung cancer (NSCLC), its outcomes are unsatisfactory. S‐1 is an oral fluoropyrimidine agent that consists of tegafur, 5‐ chloro‐2, 4‐dihydroxypyridine, and potassium oxonate. S‐1 is approved for patients with gastric cancer in 7 Asian countries and 15 European countries. It is also approved for patients with eight type of cancers, including NSCLC, in Japan. We evaluated the efficacy and toxicity of S‐1 and paclitaxel (PTX) combination therapy in patients with previously treated NSCLC. Methods. Oral S‐1 was administered thrice weekly on days 1–14 at 80, 100, and 120 mg/day in patients with body surface areas of <1.25, 1.25–1.5, and >1.5 m 2 , respectively. PTX was administered at 80 mg/m 2 on days 1 and 8. Primary endpoint was response rate, and secondary endpoints were progression‐free survival (PFS), overall survival (OS), and safety. Results. Forty patients were enrolled, with response and disease control rates of 27.5% and 75.0%, respectively (Fig. 1). Median PFS and OS were 6.5 and 20.7 months, respectively. Grade 3/4 anemia and thrombocytopenia were seen in five (12%) and one (2%) patients, respectively. Febrile neutropenia occurred in three patients (7%). Common grade 3/4 nonhematological toxicities were stomatitis (5% of patients), diarrhea (7% of patients), and interstitial lung disease (one patient). No treatment‐related deaths were observed. Conclusion. This S‐1 and PTX cotherapy dose and schedule showed satisfactory efficacy, with mild toxicities, in patients with previously treated advanced NSCLC.

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Phase I/II trial of a biweekly combination of S-1 plus docetaxel in patients with previously treated non-small cell lung cancer (KRSG-0601)

Cited by 7 publications

References 36 publications

Hapten-enhanced therapeutic effect in advanced stages of lung cancer by ultra-minimum incision personalized intratumoral chemoimmunotherapy therapy

Hapten-enhanced therapeutic effect in advanced stages of lung cancer by ultra-minimum incision personalized intratumoral chemoimmunotherapy therapy

miR-141 regulation of EIF4E expression affects docetaxel chemoresistance of non-small cell lung cancer

Phase II Study of S-1 and Paclitaxel Combination Therapy in Patients with Previously Treated Non-Small Cell Lung Cancer

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