Phase II study of 5-day continuous infusion ofcis-diamminedichloroplatinum(II) in the treatment of non-small-cell lung cancer

Saito, Yoshikuni; Mori, Kiyoshi; Tominaga, Keigo; Yokoi, K; Miyazawa, Naoto

doi:10.1007/bf02994086

Cited by 13 publications

(6 citation statements)

References 6 publications

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“…In these patients, stomatitis especially was more severe in the daily continuous infusion. Several investigators have reported that GI toxicities in prolonged infusion of CDDP, as a single agent, were equal to or less than those in single short-term infusion (7)(8)(9)(10). The results of these investigations are different from ours.…”

Section: Discussioncontrasting

confidence: 56%

“…However, the administration schedule of CDDP is still controversial. When CDDP is used as a single agent, currently used administration schedules of CDDP are single short-term infusion (6), daily short-term infusion (6) and daily continuous infusion (7)(8)(9)(10). The most common administration schedule of CDDP is single short-term infusion, followed by daily short-term infusion.…”

Section: Introductionmentioning

confidence: 99%

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Pharmacokinetics of Cisplatin in Combined Cisplatin and 5-Fluorouracil Therapy: A Comparative Study of Three Different Schedules of Cisplatin Administration

Ikeda

Terashima

Kawamura

et al. 1998

Japanese Journal of Clinical Oncology

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Background: Cisplatin is widely used in combination chemotherapy against a variety of tumors; however, the optimal administration schedule of cisplatin is still controversial. To clarify the pharmacokinetic differences according to the administration schedules of cisplatin, we compared three different administration schedules of cisplatin such as single short-term infusion, daily short-term infusion and daily continuous infusion in combination with 5-fluorouracil. Preliminary clinical responses and toxicities were also investigated. Methods: A total of 12 courses in combination of cisplatin and 5-fluorouracil therapy was studied. The schedules of cisplatin tested were as follows: single short-term infusion (80 mg/m 2 , day 1,2 h div., n =4),daily short-term infusion (20mg/m 2 , days 1 to 5, 2 h div., n =4), daily continuous infusion (100 mg/m 2 , 120 h, n = 4). In all schedules, 5-fluorouracil was continuously administered at a dose of 800 mg/m 2/day on days 1 to 5. The area under the time-concentration curve (AUC) and the maximum concentration (C max ) of total and free Pt were investigated. Results: The highest AUC of total and free Pt and the lowest C max of free Pt were observed in the daily continuous infusion (total AUC; 162.53± 18.39~g h/ml, free AUC; 5.50±0.9~g h/ml, free Cmax; 0.07±0.01 Ilg /ml, mean ± SEM).Two patients in the single short-term infusion and one patient in the daily continuous infusion indicated partial responses clinically. No nephrotoxicity or ototoxicity was observed. All toxicities were mild and tolerable in all regimens; however, the incidence of GI toxicity in daily continuous infusion seemed to be relatively higher. Conclusions: Daily continuous infusion of cisplatin gave the best pharmacokinetic results and to evaluate the clinical advantage of this schedule a prospective randomized trial should be conducted with sufficient numbers of patients.

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Section: Discussioncontrasting

confidence: 56%

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics of Cisplatin in Combined Cisplatin and 5-Fluorouracil Therapy: A Comparative Study of Three Different Schedules of Cisplatin Administration

Ikeda

Terashima

Kawamura

et al. 1998

Japanese Journal of Clinical Oncology

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“…Weekly administration and an intravenous CI schedule for several agents may improve efficacy and decrease toxicity, compared with the use of conventional i.v. bolus injections (Jacobs et al, 1978;Carlson and Sikic, 1983;Vogelzang, 1984;Saito et al, 1990;Miles et al, 1991). For some drugs, conventional intermittent scheduling every 3-4 weeks may be inferior to alternative means of drug delivery (O'Dwyer and Comis, 1989).…”

Section: Discussionmentioning

confidence: 99%

A phase II study of cisplatin, vindesine and continuously infused 5-fluorouracil in the treatment of advanced non-small-cell lung cancer

Nakano

Ikegami²,

Nakamura³

et al. 1996

Br J Cancer

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Summary Fifty-two previously untreated patients with advanced non-small-cell lung cancer (NSCLC) were treated on a 14 day cycle with cisplatin (60 mg m2 iv.) and vindesine (3 mg m-2 i.v.) on day 1, followed by a 3 day continuous infusion of 5-fluorouracil (800 mg m-2 day-') starting on al., 1984;Dhingra et al., 1985; Kawahara et al., 1991). Treatment regimens in which one further active chemotherapeutic agent has been added to vinca alkaloid and cisplatin have been tried in an attempt to improve response and survival rates. The combination of mitomycin with VP (MVP) has been reported to achieve response rates of 20-61% (Kris et al., 1986; Einhorn et al., 1986; Miller et al., 1986; Joss et al., 1990;Fukuoka et al., 1991). Although these intensive combination chemotherapy regimens achieve an improvement in objective response, serious drug-related toxicity is often experienced. Active chemotherapeutic regimens that are less toxic would therefore be desirable.Although 5-fluorouracil (5-FU) shows limited activity as a single agent in NSCLC, it reacts synergistically with CDDP against murine tumours (Schabel et al., 1979; Mabel and Little, 1979). This has prompted clinical studies of the combination of CDDP and 5-FU against NSCLC. Weiden et al. (1985) have reported a response rate of 37% in NSCLC using this combination. Continuous infusion (CI) of 5-FU has been found to increase the therapeutic response and decrease myelosuppression compared with the use of bolus injections (Seifert et al., 1975;Kish et al., 1985). Decker et al. (1983) found the combination of CDDP and a 5 day infusion of 5-FU useful in the treatment of head and neck cancers. They reported a 94% response rate, including a complete response rate of 63%. In a pilot study by the Mid-Atlantic Oncology Program, CDDP (120 mg m-2) infused over 24 h + CI 5-FU gave a response rate of 47% in advanced NSCLC (Heim et al., 1986). Toxicology profiles of these CDDP + 5-FU regimens indicate less haematological and nephrological toxicity than standard dose VP and MVP regimens. However, a higher incidence of severe mucositis was observed, and, if doxorubicin was also included, clinically significant myelosuppression, similar to that encountered with VP and MVP regimens, was also experienced (Ruckdeschel et al., 1981). Although improved response rates have been achieved, an optimum dose and schedule has yet to be identified.These reports encouraged us to perform a phase II trial of CDDP and VDS in combination with CI 5-FU against advanced NSCLC. We decided to administer VP separately from CI 5-FU, in an attempt to minimise toxicity without affecting efficacy. In most of the earlier studies CDDP and 5-FU were administered on the same day. The trial was designed so that CDDP + VDS and CI 5-FU were injected on alternate weeks. The immediate objectives were to determine the major objective response rate to this treatment programme, and to define the toxicities involved. The activity of this combination against advanced NSCLC has not been studied previously.Patients a...

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“…Three hours after completion of the docetaxel infusion, 20 mg/m 2 of cisplatin was given daily for 5 days by continuous intravenous infusion. One third of the daily dose was administered every 8 h dissolved in 800 ml of physiological saline [14] . The course was repeated every 4 weeks.…”

Section: Treatmentmentioning

confidence: 99%

“…However, compared with short-term intravenous infusion, 5-day continuous infusion makes inpatient hospitalization for at least 5 days necessary, and the duration of confi nement for the purpose of infusion is lengthy and therefore onerous for the patient. The effi cacy and safety of a continuous infusion lasting 5 days (24 h a day) were confi rmed in our facility and some other facilities [10,[14][15][16] . In addition, combination chemotherapy of infusional CDDP with vindesine or CPT-11 was found to have high response rates in treating NSCLC [17,18] .…”

Section: Introductionmentioning

confidence: 99%

A Phase II Study of Docetaxel and Infusional Cisplatin in Advanced Non-Small-Cell Lung Cancer

Mori

Kamiyama²,

Kondo³

et al. 2005

Chemotherapy

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Background: To evaluate the efficacy and safety of combination chemotherapy of cisplatin (5-day continuous infusion) and docetaxel for the treatment of previously untreated patients with advanced non-small-cell lung cancer (NSCLC). Materials and Methods: Eligible patients had an ECOG performance status of 0–2 with measurable NSCLC. Patients received continuous infusion cisplatin 20 mg/m²/day on 5 days and bolus docetaxel 60 mg/m²/day (day 1; PiD therapy) at a 4-week interval. Results: Forty-three patients were enrolled. The mean number of cycles administered per patient was 2, and ranged from 1 to 4. The response rate was 49% (95% confidence interval, 33.9–63.8%). The median survival time was 47 weeks and the 1-year survival rate was 47%. The major toxic effects were grade 3 or 4, neutropenia (88%), leukopenia (81%), thrombocytopenia (14%) and anemia (42%). There were no treatment-related deaths. Conclusion: PiD therapy was a well-tolerated and active regimen for patients with advanced NSCLC. The major toxicity was neutropenia.

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Phase II study of 5-day continuous infusion ofcis-diamminedichloroplatinum(II) in the treatment of non-small-cell lung cancer

Cited by 13 publications

References 6 publications

Pharmacokinetics of Cisplatin in Combined Cisplatin and 5-Fluorouracil Therapy: A Comparative Study of Three Different Schedules of Cisplatin Administration

Pharmacokinetics of Cisplatin in Combined Cisplatin and 5-Fluorouracil Therapy: A Comparative Study of Three Different Schedules of Cisplatin Administration

A phase II study of cisplatin, vindesine and continuously infused 5-fluorouracil in the treatment of advanced non-small-cell lung cancer

A Phase II Study of Docetaxel and Infusional Cisplatin in Advanced Non-Small-Cell Lung Cancer

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