Comparison of docetaxel and docetaxel–irinotecan combination as second-line chemotherapy in advanced non-small-cell lung cancer: a randomized phase II trial

Pectasides, D.; Pectasides, Melina; Farmakis, Dimitrios; Kostopoulou, V.; Nikolaou, Maria; Gaglia, A.; Koumpou, Maria; Mylonakis, N.; Xiros, Nikolaos I.; Economopoulos, Theofanis; Raptis, Sotirios A.

doi:10.1093/annonc/mdi053

Cited by 76 publications

(54 citation statements)

References 17 publications

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“…A total of 3.5% of cycles of combination chemotherapy were complicated by grade III/IV diarrhoea compared with 0.9% of those using docetaxel alone, and one patient in arm B died of enterococcal septicaemia. While this toxicity pattern has been reported in other phase II studies of docetaxel -irinotecan combinations, it is generally considered acceptable and is not affected by regimen scheduling (Kurtz et al, 2003;Pectasides et al, 2005;Wachters et al, 2005). While such differences were apparent using conventional toxicity scores, no significant QoL differences emerged (either on global measures or on the symptom-specific subscales).…”

Section: Discussionmentioning

confidence: 66%

SCOTROC 2B: feasibility of carboplatin followed by docetaxel or docetaxel–irinotecan as first-line therapy for ovarian cancer

et al. 2005

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The feasibility of combination irinotecan, carboplatin and docetaxel chemotherapy as first-line treatment for advanced epithelial ovarian carcinoma was assessed. One hundred patients were randomised to receive four 3-weekly cycles of carboplatin (area under the curve (AUC) 7) followed by four 3-weekly cycles of docetaxel 100 mg m À2 (arm A, n ¼ 51) or docetaxel 60 mg m À2 with irinotecan 200 mg m À2 (arm B, n ¼ 49). Neither arm met the formal feasibility criterion of an eight-cycle treatment completion rate that was statistically greater than 60% (arm A 71% (90% confidence interval (CI) 58 -81%; P ¼ 0.079; arm B 67% (90% CI 55 -78%; P ¼ 0.184)). Median-dose intensities were 485% of planned dose for all agents. In arms A and B, 15.6 and 12.2% of patients, respectively, withdrew owing to treatment-related toxicity. Grade 3 -4 sensory neurotoxicity was more common in arm A (1.9 vs 0%) and grade 3 -4 diarrhoea was more common in arm B (0.6 vs 3.5%). Of patients with radiologically evaluable disease at baseline, 50 and 48% responded to therapy in arms A and B, respectively; at median 17.1 months' follow-up, median progression-free survival was 17.1 and 15.9 months, respectively. Although both arms just failed to meet the formal statistical feasibility criteria, the observed completion rates of around 70% were reasonable. The addition of irinotecan to first-line carboplatin and docetaxel chemotherapy was generally well tolerated although associated with increased gastrointestinal toxicity. Further exploratory studies of topoisomerase-I inhibitors in this setting may be warranted.

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Section: Discussionmentioning

confidence: 66%

SCOTROC 2B: feasibility of carboplatin followed by docetaxel or docetaxel–irinotecan as first-line therapy for ovarian cancer

et al. 2005

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“…Although there have been several studies on the two-drug treatment of docetaxel, all of these were phase I and II trials, and yielded inconsistent results. Certain studies reported that a two-agent regimen based on docetaxel was better than docetaxel alone and significantly improved TTP or progression-free survival (PFS) (15)(16)(17), while different results were yielded in another study. Takeda et al reported that the RR, PFS and OS observed with docetaxel alone were similar to those observed using the combination treatment (18).…”

Section: Discussionmentioning

confidence: 99%

Phase II trial of capecitabine combined with docetaxel in previously treated patients with non-small cell lung cancer: A randomized controlled study

et al. 2012

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Abstract. Docetaxel alone has been confirmed to be beneficial to patients with advanced previously treated non-small cell lung cancer (NSCLC). However, the duration and survival time is short. The study of two-agent combination regimens has important clinical significance. We conducted this randomized controlled phase II trial to comparatively evaluate the efficacy and side effects of capecitabine combined with docetaxel in previously treated patients with NSCLC. Patients with previously treated NSCLC who failed first-line chemotherapy were randomized into two groups; one received capecitabine combined with docetaxel (XT group) and the other received docetaxel alone (T group). Patients in the XT group received chemotherapy as follows: capecitabine 625 mg/m 2 , p.o. bid, days 5-18; and docetaxel 30 mg/m 2 , days 1 and 8, while patients in the T group received docetaxel 35 mg/m 2 on days 1 and 8. The primary endpoint was time to progression (TTP), and secondary endpoints were overall survival (OS), response rate (RR) and disease control rate (DCR). Forty-eight patients were recruited (23 in the XT group and 25 in the T group). TTP, median survival time (MST) and 1-year OS rate in the XT group and the T group were 7 months, 12 months, 47.6% and 3 months, 12 months, 39.6%, respectively. The TTP in the XT group was significantly longer compared to that in the T group (χ 2 =4.763, p=0.029). The RR and DCR in the XT group and T group were 13.0% (3/23), 78.3% (18/23) and 12.0% (3/25), 76% (19/25), respectively. The difference was not significant (p>0.05). The major side effects observed in the two groups were neutropenia, fatigue and nausea, and toxicities were mild to modest. No severe cases of hand-foot syndrome were observed in the XT group. In conclusion, compared with docetaxel alone, capecitabine combined with docetaxel for patients with previously treated NSCLC achieved a significantly longer TTP and this regimen was well tolerated. The relatively high median TTP, 1-year OS rate and DCR encourage further evaluation of this regimen in a randomized phase III trial.

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“…These trials showed that combined chemotherapy significantly increases response rate and progression-free survival, but is more toxic and does not improve overall survival compared to single-agent chemotherapy (Georgoulias et al, 2004;Georgoulias et al, 2005;Pectasides et al, 2005;Wachters et al, 2005;Smit et al, 2008;Di et al, 2009;Gebbia et al, 2009;Takeda et al, 2009;Tucker, 2010) A number of studies single-agent chemotherapy with gemcitabine as second-line treatment in advanced NSCLC have been showed that median OS, 22 weeks to 8.3 months, RR 3-25% (Androulakis et al, 1998;Crino et al, 1999;Gridelli et al, 1999). Coskun et al study,21 patients treated with single agent gemcitabine as a secondline treatment and reported a partial response rate 19%, stabil disease rate 29%, median OS was 36 weeks.…”

Section: Discussionmentioning

confidence: 99%

Gemcitabine Plus Paclitaxel as Second-line Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer

Baykara¹,

Coşkun²,

Berk³

et al. 2012

Asian Pacific Journal of Cancer Prevention

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Purpose: The aim of this retrospective study was to determine response rates, progression-free survival (PFS), overall survival (OS) and toxicity of gemcitabine and paclitaxel combinations with advanced or metastatic non-small cell lung cancer patients (NSCLC) who have progressive disease after platinum-based first-line chemotherapy. Methods: We retrospectively evaluated the file records of patients treated with gemcitabine plus paclitaxel in advanced or metastatic NSCLC cases in a second-line setting. The chemotherapy schedule was as follows: gemcitabine 1500 mg/m 2 and paclitaxel 150 mg/m 2 administered every two weeks. Results: Forty-eight patients (45 male, 3 female) were evaluated; stage IIIB/IV 6/42; PS0, 8.3%, PS1, 72.9%, PS2, 18.8%; median age, 56 years old (range 38-76). Six (12.5%) patients showed a partial response (PR), 13 (27.1%) stable disease (SD), and 27 (56.3%) progressive disease (PD). The median OS was 6.63 months (95% CI 4.0-9.2); the median PFS was 2.7 months (95% CI 1.8-3.6). Grade 3 and 4 hematologic toxicities, including neutropenia (n=4, 8.4%), and anemia (n=3, 6.3%) were encountered, but no grade 3 or 4 thrombocytopenia. One patient developed febrile neutropenia. There were no interruption for reasons of toxicity and no exitus related to therapy. Conclusion: The combination of two-weekly gemcitabine plus paclitaxel was an effective and well-tolerated second-line chemotherapy regimen for advanced or metastatic NSCLC patients previously treated with platinum-containing chemotherapy. Although the most common and dose limiting toxicities were neutropenia and neuropathy, this regimen was tolerated well by the patients.

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Comparison of docetaxel and docetaxel–irinotecan combination as second-line chemotherapy in advanced non-small-cell lung cancer: a randomized phase II trial

Abstract: The administration of irinotecan with docetaxel in platinum-refractory NSCLC prolonged TTP, but did not improve significantly RR, median survival or 1-year survival. Second-line docetaxel monotherapy offers significant and reproducible efficacy in platinum-refractory NSCLC.

Cited by 76 publications

References 17 publications

SCOTROC 2B: feasibility of carboplatin followed by docetaxel or docetaxel–irinotecan as first-line therapy for ovarian cancer

SCOTROC 2B: feasibility of carboplatin followed by docetaxel or docetaxel–irinotecan as first-line therapy for ovarian cancer

Phase II trial of capecitabine combined with docetaxel in previously treated patients with non-small cell lung cancer: A randomized controlled study

Gemcitabine Plus Paclitaxel as Second-line Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer

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