Randomized, multicenter, phase II study of gemcitabine plus cisplatin versus gemcitabine plus carboplatin in patients with advanced non-small cell lung cancer

Mazzanti, Paola; Massacesi, Cristian; Rocchi, Marco; Mattioli, Rodolfo; Lippe, P.; Trivisonne, R.; Buzzi, Franco; Signoribus, G. De; Tuveri, Guido; Rossi, G.; Lullo, Liberato Di; Sturba, F.; Morale, Donatella; Catanzani, S.; Pilone, Alberta; Bonsignori, M.; Battelli, T

doi:10.1016/s0169-5002(03)00140-5

Cited by 69 publications

(51 citation statements)

References 22 publications

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“…The same schedule given for a maximum of six cycles in a similar patient population was reported to induce grade 1 -4 nephrotoxicity in only 7% of patients (McGuire et al, 1996). Cisplatin 80 mg m À2 day 2 plus gemcitabine 1200 mg m À2 days 1 and 8 given every 3 weeks up to six cycles to patients with advanced non-small-cell lung cancer induced renal side effects grades 1 -4 in 6.1% of patients (Mazzanti et al, 2003). Although the number of patients treated with cisplatin at a cumulative dose X450 mg m À2 according to stage I of our study was small, the absence of nephrotoxicity when given concurrently with BNP7787 X18.4 g m À2 , being a molar ratio of 225 : 1, may suggest some degree of nephroprotection.…”

Section: Discussionmentioning

confidence: 85%

“…In the ovarian cancer patients treated with cisplatin 75 mg m À2 plus cyclophosphamide 750 mg m À2 every 3 weeks for six to 12 cycles, the incidence of peripheral neuropathy grades 1 -3 was 46% (Neijt et al, 1987), and when given for only six cycles, this was grades 1 -4 in 21% of patients (McGuire et al, 1996). In non-small-cell lung cancer patients treated with cisplatin 80 mg m À2 day 2 plus gemcitabine 1200 mg m À2 days 1 and 8 every 3 weeks up to six cycles, the incidence of peripheral neuropathy grades 1 -4 was 12.9% (Mazzanti et al, 2003). The cumulative dose of cisplatin at the start of paresthesias in our study varied between 375 and 675 mg m À2 , and notably none exceeded grade 1.…”

Section: Discussionmentioning

confidence: 99%

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Phase I and pharmacokinetic study of the novel chemoprotector BNP7787 in combination with cisplatin and attempt to eliminate the hydration schedule

et al. 2005

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BNP7787 (disodium 2,20 -dithio-bis-ethane sulphonate; Tavoceptt) is a novel agent developed to protect against cisplatin (cisdiammine-dichloroplatinum(II))-associated chronic toxicities. In this study, we determined the recommended dose of BNP7787 when preceding a fixed dose of cisplatin, the pharmacokinetics (PKs) and the possible reduction of saline hydration. Patients with advanced solid tumours received BNP7787 in escalating doses of 4.1 -41 g m À2 as a 15-min intravenous (i.v.) infusion followed by cisplatin 75 mg m À2 as a 60-min i.v. infusion together with pre-and postcisplatin saline hydration in a volume of 2200 ml; cycles were repeated every 3 weeks. PK was carried out using BNP7787, cisplatin and the combination. Twenty-five patients were enrolled in stage I of the study to determine the recommended dose of BNP7787. No dose-limiting toxicity was reached. The highest dose level of 41 g m À2 resulted in a low incidence of grade 2 toxicities, being nausea and vomiting, dry mouth or bad taste and i.v. injection site discomfort. Doses of BNP7787 X18.4 g m À2 did not show a drug interaction between BNP7787 and cisplatin. In stage II of the study, patients received a fixed dose of BNP7787 of 18.4 g m À2 preceding cisplatin and were entered in prespecified reduced saline hydration steps. A total of 21 patients in cohorts of six to nine patients received reduced saline hydration of 1600 ml (step A), 1000 ml (step B) and 500 ml (step C). In step C, two out of six evaluable patients experienced grade 1 nephrotoxicity. Cisplatin acute toxicities in all 46 patients were as expected. Only five patients complained of paresthesias grade 1 and six developed slight audiometric changes. Partial tumour response was observed in four patients and stable disease in 15 patients. In conclusion, BNP7787 was tolerated well up to doses of 41 g m À2 . The recommended dose of 18.4 g m À2 enabled safe reduction of the saline hydration schedule for cisplatin to 1000 ml. Further studies will assess whether BNP7787 offers protection against platinum-related late side effects.

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Section: Discussionmentioning

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Phase I and pharmacokinetic study of the novel chemoprotector BNP7787 in combination with cisplatin and attempt to eliminate the hydration schedule

et al. 2005

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“…Several trials in the past compared regimens containing cisplatin vs carboplatin with conflicting results [26][27][28][29][30][31][32][33]. In 2007, an individual patient data meta-analysis performed by Ardizzoni et al [34], including 9 of these trials and comparing cisplatin VS carboplatin-based chemotherapy in 2968 NSCLC patients, showed a significant improvement of ORR in favour of cisplatin arm (30% VS 24%; OR: 1.37, P < 0.001), while no significant differences between two arms were observed in survival rate.…”

Section: Citaɵonmentioning

confidence: 99%

What can platinum offer yet in the treatment of PS2 NSCLC patients? A systematic review and meta-analysis

Bronte

Rolfo

Passiglia

et al. 2015

Critical Reviews in Oncology/Hematology

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“…The evidence report on the carboplatin plus gemcitabine regimen in Japan was few compared to those of carboplatin plus paclitaxel, almost all being reported from overseas [22,23]. The gemcitabine plus carboplatin regimen was allowed to administer in an outpatients setting due to the short time of drip infusion and mild nonhematological toxicities such as alopecia and gastroenterological symptoms, however, thrombocytopenia should require attention.…”

Section: Discussionmentioning

confidence: 99%

Adjuvant Chemotherapy of Gemcitabine plus Carboplatin versus Paclitaxel plus Carboplatin in Patients with Resected Non-Small Cell Lung Cancer

Ayabe¹,

Tomita²,

Nakamura³

2013

JCT

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Background: This retrospective study was to evaluate the efficacy and toxicity of gemcitabine plus carboplatin (GC regimen) and paclitaxel plus carboplatin (PC regimen) combination chemotherapy administered as an adjuvant therapy after complete resection of non-small cell lung cancer. Methods: Forty-four patients (GC regimen, n = 29; PC regimen, n = 15) received gemcitabine at a dose of 1000 mg/m 2 on days 1 and 8, and carboplatin with the target dose of area under the curve (AUC) of 4 on day 8 every 28 days and paclitaxel at a dose of 70 mg/m 2 on days 1, 8 and 15, and carboplatin with the target dose of AUC of 5 on day 1 every 28 days. Results: A total of 130 cycles of the treatment were administered (averaged, 3.1 in GC arm and 2.7 cycles in PC arm). Forty-three patients (97.7%) completed the scheduled cycles. One patient (2.3%) was discontinued due to grade 4 pneumonia. The dose was reduced in 2 patients (4.5%) due to grade 4 thrombocytopenia. Grade 3/4 neutropenia was significantly observed in the PC group (GC: 12/29, 41.4%; PC: 11/15, 73.3%, p = 0.0443). The nonhematological toxicities were mild. Grade 1/2 alanine aminotransferase and aspartate aminotransferase in the GC group was significantly observed higher compared to those of the PC group (GC: 20/29, 69.0%; PC: 4/15, 26.7%, p = 0.0076). Grade 1/2 alopecia was significantly observed in the PC group (GC: 0/25, 0.0%; PC: 13/15, 86.7%, p < 0.0001). There was no treatment-related death. The median survival time (MST) of the entire GC group was 784 days, the 3-year overall survival (OS) was 75.9%, and 3-year recurrence-free survival (RFS) was 65.5%. The MST of the entire PC group was 963 days, the 3-year OS was 80.0%, and the 3-year RFS was 60.0%. Conclusion: These results demonstrate that the GC and PC combination chemotherapies are efficacious and feasible regimens, which should be considered as one of the standard therapies for adjuvant therapy.

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Randomized, multicenter, phase II study of gemcitabine plus cisplatin versus gemcitabine plus carboplatin in patients with advanced non-small cell lung cancer

Cited by 69 publications

References 22 publications

Phase I and pharmacokinetic study of the novel chemoprotector BNP7787 in combination with cisplatin and attempt to eliminate the hydration schedule

Phase I and pharmacokinetic study of the novel chemoprotector BNP7787 in combination with cisplatin and attempt to eliminate the hydration schedule

What can platinum offer yet in the treatment of PS2 NSCLC patients? A systematic review and meta-analysis

Adjuvant Chemotherapy of Gemcitabine plus Carboplatin versus Paclitaxel plus Carboplatin in Patients with Resected Non-Small Cell Lung Cancer

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