Carboplatin and docetaxel in advanced non-small-cell lung cancer: results of a multicenter phase II study

Ramalingam, Sakkaraiappan; Dobbs, T.; Einzig, Avi I.; Wojtowicz‐Praga, Slawomir; Cascino, Marianne; Bonomi, P.; Belani, Chandra P.

doi:10.1007/s00280-003-0752-3

Cited by 12 publications

(7 citation statements)

References 25 publications

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“…9,29 Numerous studies have demonstrated acceptable rates of OS times (10 -15 months) and good tolerability in chemonaïve patients with advanced NSCLC who were treated with Doc/Carb. [12][13][14][15][16][17]19 In this study of patients with nonsquamous cell carcinoma, the median OS with Doc/Carb was comparable with these previous studies (14.7 months). However, the current study was not sufficiently powered to determine whether there were significant differences in median OS, and the HR for median OS between Pem/Carb-and Doc/Carb-treated patients was not statistically significant (adjusted HR ϭ 0.93, p ϭ 0.698).…”

Section: Discussionsupporting

confidence: 86%

“…Although docetaxel/carboplatin (Doc/Carb) is a wellaccepted first-line option for patients with advanced NSCLC, [12][13][14][15][16][17][18][19][20] relatively few studies have assessed first-line treatment with pemetrexed/carboplatin (Pem/Carb), particularly in patients with advanced, nonsquamous NSCLC. [21][22][23][24][25] Moreover, no phase 3 randomized controlled studies have been conducted to directly compare Pem/Carb with Doc/Carb or any platinum/taxane combination as first-line treatment for patients with nonsquamous NSCLC.…”

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confidence: 99%

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A Randomized Phase 3 Trial Comparing Pemetrexed/Carboplatin and Docetaxel/Carboplatin as First-Line Treatment for Advanced, Nonsquamous Non-small Cell Lung Cancer

Rodrigues-Pereira¹,

Kim

Magallanes³

et al. 2011

Journal of Thoracic Oncology

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Section: Discussionsupporting

confidence: 86%

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confidence: 99%

A Randomized Phase 3 Trial Comparing Pemetrexed/Carboplatin and Docetaxel/Carboplatin as First-Line Treatment for Advanced, Nonsquamous Non-small Cell Lung Cancer

Rodrigues-Pereira¹,

Kim

Magallanes³

et al. 2011

Journal of Thoracic Oncology

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“…The combination of docetaxel with carboplatin has been tested successfully in various phase II studies conducted over the last 3 years [18,19,20,21,22]. Moreover, the combination docetaxel-carboplatin has demonstrated the best therapeutic index in the recent TAX326 randomized multi-institutional trial in advanced (IIIB/IV) NSCLC comparing docetaxel-carboplatin with vinorelbine-cisplatin and paclitaxel-carboplatin [23].…”

Section: Discussionmentioning

confidence: 99%

“…The principal toxicities in the above phase I studies were: neutropenia which was the main DLT of the regimen, with grade 3/4 neutropenia occurring in 14% of cycles, a 5% incidence of FN with no associated septic death, uncommon grade 3/4 thrombocytopenia (2%), grade 3/4 diarrhea in 14% of patients, whilst neurotoxicity, fatigue and mucositis were extremely rare. Overall, 5 phase II studies evaluating the docetaxel-carboplatin combination have been conducted in advanced (stage IIIB/IV) NSCLC with doses of docetaxel ranging from 60 to 100 mg/m 2 and carboplatin AUC = 5 or 6 [18,19,20,21,22]. Overall RRs have ranged from 16–39%, TTP from 5.5 to 7 months, median OS from 9 to 13.9 months, and 1-year survival from 44 to 53%.…”

Section: Discussionmentioning

confidence: 99%

A Phase II Study of the Docetaxel- Ifosfamide-Carboplatin Combination in Advanced Non-Small-Cell Lung Cancer

et al. 2005

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Purpose: In the present phase II study we evaluated the docetaxel-ifosfamide-carboplatin (DICb) combination in the outpatient setting in patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Patients with advanced NSCLC (stages IIIB/IV), WHO performance status (PS) <2, and no prior chemotherapy were eligible. Chemotherapy drug doses were: docetaxel: 80 mg/m², ifosfamide: 3.5 g/m², and carboplatin at a target area under the curve of 5 (based on Calvert’s formula), all on day 1, followed by prophylactic G-CSF. Results: Fourty patients were entered and all are evaluable for response and toxicity: median age: 64 (48–72); PS: 1 (0–1); gender: 29 males/11 females; stages: IIIB: 13 (33%), IV: 27 (67%). Metastatic sites at diagnosis included: lymph nodes: 25; bone: 7; liver: 4; brain: 5; lung nodules: 13; adrenals: 6. Responses were as follows: 22/40 [55%; 95% confidence interval (CI), 54–81%] evaluable patients responded: 4 complete responses, 18 partial responses, 11 had stable disease, and 7 had progressive disease. The median response duration was 7 months (range 2–14 months), median time to progression 9 months (range 2–18 months) and median overall survival 11 months (range 3–46+ months). 1-year survival was 47.5%. Grade 3/4 toxicities included: neutropenia 28/40, with 12 developing grade 4 and 12% febrile neutropenia, thrombocytopenia grade 3: 3/40 and grade 4: 1/40, no grade 3 neuropathy, grade 1 CNS toxicity in 3, no renal toxicity, 8 grade 2 diarrhea and 4 grade 3 vomiting. Conclusion: In the present phase II study the DICb combination yielded important activity and good tolerability in advanced NSCLC.

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“…This formula is widely used in the treatment of several type of carcinoma. [23][24][25][26][27] Although it is generally considered that creatinine clearance does not accurately reflect the glomerular filtration rate, 11,12) creatinine clearance is frequently used instead because of the inconvenience of measuring the glomerular filtration rate directly. Actually, some reported an arrangement of Calvert's formula using creatinine clearance.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Calvert's Formula for Dosage Adjustment of Carboplatin in Japanese Patients with Hormone Refractory Prostate Cancer

Sato

Yano

Jiko

et al. 2006

Biological & Pharmaceutical Bulletin

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Carboplatin, an analogue of cisplatin, was introduced in 1981 and has proven effective against various malignancies. Carboplatin has less nonhematological toxicity such as renal failure than its parent compound cisplatin, 1) and thrombocytopenia is a dose-limiting factor of this drug.2) Since the 1990's, carboplatin in combination with paclitaxel has been used in the treatment of several solid tumors such as ovarian, breast and lung cancers. [3][4][5] At present, no chemotherapy is considered effective enough for prostate cancer, although regimens of mitoxantrone or taxanes was recently reported to be effective. 6) Especially, the combination therapy of carboplatin and paclitaxel has been regarded as valid for hormone refractory prostate carcinoma.7,8) Therefore, we used a regimen of paclitaxel and carboplatin every four weeks as performed in the treatment of other solid tumors, to prolong the life of patients with hormone refractory prostate cancer.Dosages of carboplatin are frequently determined based on Calvert's formula: dose (mg)ϭtarget AUCϫ(GFRϩ25), where AUC is the area under the concentration versus time curve (mg · min/ml) for free carboplatin, and GFR is the glomerular filtration rate (ml/min). 9) Since carboplatin is eliminated depending on glomerular filtration, 10) Calvert et al. 9) designed this simple formula to predict the AUC based on the glomerular filtration rate. The efficacy and toxicity of carboplatin were more closely related to AUC than dosage, 2) and to control the actual AUC of carboplatin into the target range is considered to be important. Although Calvert et al. 9) primarily measured the glomerular filtration rate using the [ 51 Cr]-EDTA method, creatinine clearance is generally used instead because of the inconvenience of measuring the glomerular filtration rate directly. Moreover, it is known that creatinine clearance is higher than the glomerular filtration rate, since creatinine is not only filtered by glomeruli but secreted by renal tubules. 11,12) Therefore, using creatinine clearance in place of the glomerular filtration rate may result in an overdose of carboplatin, and several studies have been done to examine the accuracy for prediction of carboplatin clearance, or to re-arrange the Calvert's formula for various types of tumors. [13][14][15][16] However, only a limited amount of information on the pharmacokinetics of carboplatin as well as efficacy of Calvert's formula is available in Japanese cancer patients. [17][18][19] In this study, we attempted the pharmacokinetic analysis of carboplatin, and evaluated the usefulness of Calvert's formula in prostate cancer patients treated with a combination therapy of paclitaxel and carboplatin. The relationships between the pharmacokinetics of carboplatin and clinical laboratory tests as well as toxicity were also evaluated. PATIENTS AND METHODS Patients and Chemotherapy RegimenTen patients with hormone refractory prostate carcinoma were enrolled in this study. All were inpatients at the Department of Urology, Kyoto Universi...

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Carboplatin and docetaxel in advanced non-small-cell lung cancer: results of a multicenter phase II study

Abstract: The combination of carboplatin plus docetaxel is well tolerated and is effective for the treatment of patients with previously untreated advanced or metastatic non-small-cell lung cancer.

Cited by 12 publications

References 25 publications

A Randomized Phase 3 Trial Comparing Pemetrexed/Carboplatin and Docetaxel/Carboplatin as First-Line Treatment for Advanced, Nonsquamous Non-small Cell Lung Cancer

A Randomized Phase 3 Trial Comparing Pemetrexed/Carboplatin and Docetaxel/Carboplatin as First-Line Treatment for Advanced, Nonsquamous Non-small Cell Lung Cancer

A Phase II Study of the Docetaxel- Ifosfamide-Carboplatin Combination in Advanced Non-Small-Cell Lung Cancer

Evaluation of Calvert's Formula for Dosage Adjustment of Carboplatin in Japanese Patients with Hormone Refractory Prostate Cancer

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