Phase II trial of docetaxel (Taxotere®) in metastatic colorectal carcinoma

Pazdur, Richard; Lassere, Yvonne; Soh, Lay Tin; Ajani, Jaffer A.; Bready, Beth; Soo, Edward; Sugarman, Steven; Patt, Yehuda Z.; Abbruzzese, J. L.; Levin, Bernard

doi:10.1093/oxfordjournals.annonc.a058883

Cited by 49 publications

(21 citation statements)

References 6 publications

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“…The median survival time in case of S-1 given to colorectal cancer patients was consistent with data obtained on leucovorin·5-FU or interferon·5-FU [43, 44]. Compared to S-1, docetaxel [45]and topotecan [46]were less effective in cases of colorectal cancers. Thus, S-1 shows promise for potent antineoplastic effects on gastrointestinal cancers.…”

Section: Discussionsupporting

confidence: 82%

An Early Phase II Study of Oral S-1, a Newly Developed 5-Fluorouracil Derivative for Advanced and Recurrent Gastrointestinal Cancers

et al. 1999

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5-Fluorouracil (5-FU) or a 5-FU derivative 1-(2-tetrahydrofuryl)-5-fluorouracil (FT) has been widely prescribed for patients with gastrointestinal cancer. However, the phosphorylation of 5-FU in the digestive tract causes gastrointestinal toxicities. 5-FU is also rapidly degraded to α-fluoro-β-alanine after contact with dihydropyrimidine dehydrogenase (DPDase) which is mainly present in the liver. Therefore, to overcome these metabolic events, S-1, an antitumor agent was developed, based on the biochemical modulation of FT by 5-chloro-2,4-dihydroxypyridine (CDHP) and potassium oxonate (Oxo), in a molar ratio of 1:0.4:1. The antineoplastic effect of S-1, was examined in Japanese patients with advanced gastric (G) or colorectal (C) cancer in a multicenter early phase II study involving 24 centers throughout Japan. The patients were prescribed a minimum of 2 courses of S-1 orally, with each course consisting of 75 or 50 mg (in terms of FT) twice a day for 28 days followed by withdrawal for 2 weeks. Thirty-one patients with G and 31 C were entered into this study. The clinical response and extent of toxicity were evaluated in G 28 and C 30 cases, respectively. Nine (32.1%) G patients and 14 (46.7%) C patients had been treated previously with other anticancer drugs. In G patients, there was a 53.6% (15/28) and in C patients a 16.7% (5/30) response rate (90% confidence interval G 38.4–68.1% and C 8.4–30.5%) with 15 (53.6%) (G) and 5 (16.7%) (C) partial responses (PR), and these responses persisted for 79 days (G) and 120 days (C) (median value). In particular, the response rate for the primary lesion was 27.8% (5/18) (G) and 33.3% (1/3) (C). No change (NC) in the disease was observed in 4 (14.3%) (G) and 13 (43.3%) (C) patients, and in 6 (21.4%) (G) and 7 (23.3%) (C) the disease progressed (PD). At the time of analysis, the median survival was 298 days (G) and 358 days (C). Major adverse effects consisted of gastrointestinal symptoms and myelosuppression while toxicities of grade 3 or more occurred in 35.7% (10/28) (G) and 33.3% (10/30) (C). Based on these data, S-1 is considered to have positive effects in patients with advanced gastrointestinal cancer.

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Section: Discussionsupporting

confidence: 82%

An Early Phase II Study of Oral S-1, a Newly Developed 5-Fluorouracil Derivative for Advanced and Recurrent Gastrointestinal Cancers

et al. 1999

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“…There is evidence that abnormalities of the spindle checkpoint drive CIN, and in turn promote taxane resistance 154. Given that most CRCs are CIN+, this may explain the poor response of CRC to taxanes observed in phase 1 trials,155 and diploid CRCs could show a better response to taxanes.…”

Section: Discussionmentioning

confidence: 99%

Association between chromosomal instability and prognosis in colorectal cancer: a meta-analysis

Walther

Houlston²,

Tomlinson³

2008

Gut

312

240

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“…It is interesting to note that although single-agent capecitabine did not produce major responses in pretreated colorectal cancer patients in a recent study 15 and single-agent docetaxel has not shown significant antitumor activity in this malignancy, 16,17 the combination of capecitabine with docetaxel in this study resulted in major responses (partial response) in the two colorectal cancer patients who had been previously treated with either multiple chemotherapeutic or chemoembolization and biologic agents. It is interesting to note that although single-agent capecitabine did not produce major responses in pretreated colorectal cancer patients in a recent study 15 and single-agent docetaxel has not shown significant antitumor activity in this malignancy, 16,17 the combination of capecitabine with docetaxel in this study resulted in major responses (partial response) in the two colorectal cancer patients who had been previously treated with either multiple chemotherapeutic or chemoembolization and biologic agents.…”

Section: Discussionmentioning

confidence: 59%

Pharmacobiologically Based Scheduling of Capecitabine and Docetaxel Results in Antitumor Activity in Resistant Human Malignancies

Nadella

Shapiro

Otterson

et al. 2002

JCO

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Phase II trial of docetaxel (Taxotere®) in metastatic colorectal carcinoma

Cited by 49 publications

References 6 publications

An Early Phase II Study of Oral S-1, a Newly Developed 5-Fluorouracil Derivative for Advanced and Recurrent Gastrointestinal Cancers

An Early Phase II Study of Oral S-1, a Newly Developed 5-Fluorouracil Derivative for Advanced and Recurrent Gastrointestinal Cancers

Association between chromosomal instability and prognosis in colorectal cancer: a meta-analysis

Pharmacobiologically Based Scheduling of Capecitabine and Docetaxel Results in Antitumor Activity in Resistant Human Malignancies

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