Phase I trial of docetaxel and cisplatin in previously untreated patients with advanced non-small-cell lung cancer.

Millward, Michael; Zalcberg, John; Bishop, James F.; Webster, Lorraine K.; Zimet, Allan; Rischin, Danny; Toner, Guy C.; Laird, Jacqui; Cosolo, W; Urch, Maureen; Bruno, René; Loret, Camille; James, Robyn; Blanc, C.

doi:10.1200/jco.1997.15.2.750

Cited by 68 publications

(30 citation statements)

References 21 publications

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“…Subsequent studies, however, consistently raised concerns about toxicity, notably neutropenia. 1,20,21 Preclinical studies have demonstrated that docetaxel modulates the intracellular metabolism of other drugs (5-FU and cisplatin), which explains the mechanism underlying the synergistic effect.…”

Section: Discussionmentioning

confidence: 99%

A randomized phase 2 study of docetaxel and S‐1 versus docetaxel and cisplatin in advanced gastric cancer with an evaluation of SPARC expression for personalized therapy

Jeung

Rha

et al. 2010

Cancer

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BACKGROUND:The purpose of this study was to compare 2 weekly docetaxel-based regimens as first-line treatments for advanced gastric cancer and to investigate the expression of secreted protein acidic and rich in cysteine (SPARC) and its abilities to predict treatment-related clinical outcomes. METHODS: Patients were randomly selected to receive 3 weekly cycles of docetaxel (35 mg/m 2 on days 1 and 8) plus S-1 (35 mg/m 2 each twice daily on days 1-14)

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Section: Discussionmentioning

confidence: 99%

A randomized phase 2 study of docetaxel and S‐1 versus docetaxel and cisplatin in advanced gastric cancer with an evaluation of SPARC expression for personalized therapy

Jeung

Rha

et al. 2010

Cancer

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“…19,20 One study recommended a combination of docetaxel 75 mg/m 2 given over a 1-h period, followed by cisplatin 75 mg/m 2 , given over a 1-h period. 19 The other recommended two alternative combinations of these drugs, i.e., a combination of 1-h infusion of docetaxel, 100 mg/m 2 , followed by 3-h infusion of cisplatin, 75 mg/m 2 ; or docetaxel, 85 mg/m 2 , followed by cisplatin, 100 mg/m 2 . 20 Neutropenia was the predominant toxicity in these studies and in our own.…”

Section: Pk Resultsmentioning

confidence: 99%

“…The findings of two phase I studies of the combination of docetaxel and cisplatin have been published. 19,20 However, their results are not applicable to cancer patients in Japan, because there is a distinct difference in the approved doses for single-agent use of docetaxel between that in Western countries (75-100 mg/m 2 ) and that in Japan (60 mg/m 2 ). [12][13][14][15][16][17] It was therefore essential to conduct a phase I study of the combination of these drugs in Japan.…”

Section: Introductionmentioning

confidence: 93%

Phase I study of docetaxel and cisplatin for patients with previously untreated metastatic non-small-cell lung cancer: a Japanese cooperative study

et al. 2000

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Background. Docetaxel is one of the most active agents used in the treatment of advanced non-small-cell lung cancer. This phase I study was performed to determine the toxicities, maximum tolerated dose, and pharmacokinetics of the combination of docetaxel and cisplatin in patients with non-small-cell lung cancer, and to recommend a dose for phase II study. Methods.Patients were required to have previously untreated metastatic non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 2 or less, be aged between 15 and 74 years, to have a measurable lesion, and to have adequate organ function. Treatment consisted of 1-h infusion of docetaxel on day 1, followed by 2-h infusion of cisplatin (3 h after docetaxel) at the following docetaxel/cisplatin (mg/m 2 ) dose levels: 50/50, 60/50, 60/60, 60/70, and 60/80. At least three patients were accrued at each dose level. Treatment was repeated every 3 to 4 weeks for responders. Administration of granulocyte-colony stimulating factor was permitted when leukocytopenia or neutropenia of grade 3 or more occurred. Results. Of the 29 patients entered, all were assessable for toxicity and response, but 2 were excluded from analyses of dose-limiting toxicity and maximum tolerated dose. Neutropenia (grade 4, for 3 days or more; n ϭ 1), hepatic dysfunction (grade 3 or more; n ϭ 2) and renal dysfunction (grade 2 or more; n ϭ 3) were observed as dose-limiting toxicities. However, the maximum tolerated dose was not detected, even at the highest dose examined. Tumor response occurred in 13 of the 29 patients (45%; 95% confidence interval; 26%-64%). The pharmacokinetic profiles of docetaxel and cisplatin (n ϭ 17) were similar to those observed after the administration of each dose as a single agent. Conclusion. Docetaxel/cisplatin doses of 60/80 mg/m 2 were recommended for phase II study, because grade 4 neutropenia occurred in 50% or more patients at docetaxel/ cisplatin dose levels of 60/60 mg/m 2 and above, and the doses of these drugs were restricted to within the approved dose ranges for single-agent use in Japan. The responses observed in this phase I study suggest a high degree of activity of this combination against previously untreated advanced non-small-cell lung cancer and warrant a phase II study at the recommended dose level.

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“…Furthermore, it is occasionally observed after highly aggressive chemotherapies against solid tumors [5]. Two cases of NE or NEC have been reported after the appliance of pemetrexed in the treatment of NSCLC [4,10]. To date, only one case of fatal NEC has been reported after chemotherapy for MPM [11].…”

Section: Discussionmentioning

confidence: 99%

Pemetrexed-induced neutropenic enteritis and severe cutaneous hyperpigmentation in a patient with malignant pleural mesothelioma

et al. 2013

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Neutropenic enteritis (NE) or enterocolitis (NEC) is a rare, but potentially life-threatening side effect of neutropenia-inducing chemotherapy agents. Generally, its occurrence is attributed to leukemiaassociated chemotherapies. Two cases of NE have been reported after the appliance of pemetrexed for treatment of non-small cell lung cancers. To our knowledge, NE has never been reported due to treatment with pemetrexed for malignant pleural mesothelioma (MPM). We present a case of MPM in a 77-year-old male suffering from severe NE one week after the seventeenth cycle of pemetrexed in the course of maintenance therapy for MPM, which could be treated successfully with antibiotic coverage and supportive measures. Concomitantly the patient showed a severe hyperpigmentation of his entire integument sparing the palms of both hands and the soles of his feet. After exclusion of alternative causes of skin hyperpigmentation, a pemetrexed-induced cutaneous hyperpigmentation was assumed according to two previous case reports. A combination of both pemetrexed-induced side effects in one patient has not been reported to date. AbstractNeutropenic enteritis (NE) or enterocolitis (NEC) is a rare, but potentially life-threatening side effect of neutropenia-inducing chemotherapy agents.Generally, its occurrence is attributed to leukaemia-associated chemotherapies. Two cases of NE have been reported after the appliance of pemetrexed for treatment of non-small cell lung cancers. To our knowledge, NE has never been reported due to treatment with pemetrexed for malignant pleural mesothelioma (MPM). We present a case of MPM in a 77-year-old male suffering from severe NE one week after the seventeenth cycle of pemetrexed in the course of maintenance therapy for MPM, which could be treated successfully with antibiotic coverage and supportive measures. Concomitantly the patient showed a severe hyperpigmentation of his entire integument sparing the palms of both hands and the soles of his feet. After exclusion of alternative causes of skin hyperpigmentation, a pemetrexed-induced cutaneous hyperpigmentation was assumed according to two previous case reports. A combination of both pemetrexedinduced side effects in one patient has not been reported to date.

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Phase I trial of docetaxel and cisplatin in previously untreated patients with advanced non-small-cell lung cancer.

Abstract: Docetaxel 75 mg/m2 over 1 hour followed by cisplatin 75 mg/m2 over 1 hour is recommended for phase II studies. The responses seen in this phase I study suggest a high degree of activity of this combination in previously untreated advanced NSCLC.

Cited by 68 publications

References 21 publications

A randomized phase 2 study of docetaxel and S‐1 versus docetaxel and cisplatin in advanced gastric cancer with an evaluation of SPARC expression for personalized therapy

A randomized phase 2 study of docetaxel and S‐1 versus docetaxel and cisplatin in advanced gastric cancer with an evaluation of SPARC expression for personalized therapy

Phase I study of docetaxel and cisplatin for patients with previously untreated metastatic non-small-cell lung cancer: a Japanese cooperative study

Pemetrexed-induced neutropenic enteritis and severe cutaneous hyperpigmentation in a patient with malignant pleural mesothelioma

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