Carboplatin (CBDCA, JM-8) and VP-16-213 in previously untreated patients with small-cell lung cancer.

J, Bishop; Raghavan, Derek; Stuart-Harris, R.; Morstyn, George; Aroney, R. S.; Kefford, Richard; Yuen, Kally; Lee, J; Gianoutsos, Peter; Olver, Ian

doi:10.1200/jco.1987.5.10.1574

Cited by 105 publications

(30 citation statements)

References 12 publications

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“…The response rate and survival data for this pilot trial are similar to those from other reported series using platinum/etoposide and doxorubicin-based regimens (Ellis et al, 1995b;Bishop et al, 1987;Evans et al, 1988;Fukuoka et al, 1991;Roth et al, 1992). There was no survival difference between patients entered in this trial and matched controls treated in a series of chemotherapy trials with data entered prospectively on our database (Figure 2).…”

Section: Discussionsupporting

confidence: 71%

A pilot study of MVP (mitomycin-C, vinblastine and cisplatin) chemotherapy in small-cell lung cancer

Hickish

Smith²,

Nicolson³

et al. 1998

Br J Cancer

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Summary MVP chemotherapy (mitomycin C 8 mgm-2, courses 1,2,4 and 6, vinblastine 6 mgm-2, cisplatin 50 mgm-2) is an active low-toxicity regimen in non-small-cell lung cancer (NSCLC). Based on the single-agent activity of these agents in SCLC, we have conducted a phase 11 trial of MVP in SCLC. Fifty chemo-naive patients with SCLC were entered in this trial. There were 33 men and 17 women with median age 66 years (range 46-83 years); 18 patients had limited disease (LD) and 32 extensive disease (ED). WHO performance status (PS) was: three patients PS 0, 33 patients PS 1, ten patients PS 2, four patients PS 3. A maximum of six cycles was given in responding patients. On completion of chemotherapy, patients with LD obtaining complete response (CR)/good partial response (PR) received thoracic irradiation and those obtaining CR were offered entry into the ongoing MRC Prophylactic Cranial Irradiation Trial. The overall response was 79% with 17% CR and 62% PR. For LD patients, 38% obtained CR but for ED only one patient achieved CR. Median response duration for LD patients was 8 months and for ED patients 5 months. Median survival was 10 months for LD patients and 6 months for ED patients. There was complete resolution of symptoms in 24%, partial improvement in 68%, no change in 2% and progressive symptoms in 6%. As regards toxicity, 24% developed WHO grade 3/4 neutropenia, 16% grade 3/4 thrombocytopenia and 6% significant hair loss. Two patients died during the first week of treatment with neutropenic infection. Quality of life using the EORTC questionnaire (QLC-C30) with lung cancer module demonstrated significant improvements from baseline levels in emotional and cognitive functioning, global QOL, of pain, dyspnoea and cough. MVP, an effective palliative regimen for NSCLC, is also active against SCLC with low toxicity and merits comparison with more toxic conventional schedules.

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Section: Discussionsupporting

confidence: 71%

A pilot study of MVP (mitomycin-C, vinblastine and cisplatin) chemotherapy in small-cell lung cancer

Hickish

Smith²,

Nicolson³

et al. 1998

Br J Cancer

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“…Phase II studies of the combination of carboplatin and etoposide for untreated SCLC were initially reported in 1987. 27,28 The efficacy of carboplatin and etoposide combination therapy for untreated SCLC is indistinguishable from that of cisplatin and etoposide, with equivalent response rates and survival duration in randomized comparisons. 29,30 Oblimersen dose levels evaluated in the phase I study included 5 and 7 mg/kg/d.…”

Section: Introductionmentioning

confidence: 99%

Randomized Phase II Study of Carboplatin and Etoposide With or Without thebcl-2Antisense Oligonucleotide Oblimersen for Extensive-Stage Small-Cell Lung Cancer: CALGB 30103

Rudin

Salgia

Wang

et al. 2008

JCO

151

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Purpose-To assess the efficacy and toxicity of carboplatin, etoposide, and the bcl-2 antisense oligonucleotide oblimersen as initial therapy for extensive-stage small-cell lung cancer (ES-SCLC). bcl-2 has been implicated as a key factor in SCLC oncogenesis and chemotherapeutic resistance.Patients and Methods-A 3:1 randomized phase II study was performed to evaluate carboplatin and etoposide with (arm A) or without oblimersen (arm B) in 56 assessable patients with chemotherapy-naïve ES-SCLC. Outcome measures including toxicity, objective response rate, complete response rate, failure-free survival, overall survival, and 1-year survival rate.Results-Oblimersen was associated with slightly more grade 3 to 4 hematologic toxicity (88% v 60%; P = .05). Response rates were 61% (95% CI, 45% to 76%) for arm A and 60% (95% CI, 32% to 84%) for arm B. The percentage of patients alive at 1 year was 24% (95% CI, 12% to 40%) with oblimersen, and 47% (95% CI, 21% to 73%) without oblimersen. Hazard ratios for failure-free survival (1.79; P = .07) and overall survival (2.13; P = .02) suggested worse outcome

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“…In contrast, carboplatin has been given successfully at doses up to 1600 mg m-2 without substantial toxicity other than bone marrow suppression Shea et al, 1989) The dose achieved in low risk patients compares favourably with that achieved in several phase I-II studies using this combination administered systemically. Bishop et al (1987) evaluated the efficacy and toxicity of carboplatin (100 mg m-2) and etoposide (120 mg m-2) administered intravenously daily for 3 days in 94 patients with previously untreated small cell lung cancer. According to the Common Toxicity Grading Scale, Grade 3 or 4 neutropenia and thrombocytopenia occurred in 63% and 20% of patients respectively.…”

Section: Pharmacokineticsmentioning

confidence: 99%

A phase I and pharmacokinetic study of intraperitoneal carboplatin and etoposide

McClay

Goel²,

Andrews³

et al. 1993

Br J Cancer

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Summary Background We attempted to determine the maximum tolerated dose and toxicity of etoposide (VP-16) when administered in combination with carboplatin (CBDCA) (300 mg m-2) and administered via the intraperitoneal (IP) route.Methods and Materials A total of 26 patients were treated on this trial. CBDCA was administered at a fixed dose of 300 mg m-2) while Material and methodsPatient eligibility and characteristics Patients were eligible for participation in this trial if they were 18 years of age or older and had a histologically proven diagnosis of cancer that was refractory to or relapsed after conventional modes of therapy or for which no effective chemotherapy exists. All patients were fully ambulatory and had a life expectancy of at least eight weeks. Patients had to have recovered from the toxic effects of prior therapy and have normal renal (creatinine < 1.5 mg dl-') and hepatic function (bilirubin <1.5 mg%, SGOT less than three times the upper limit of normal). Hematologic parameters required a granulocyte count greater than 1,500 mm-3 and platelet count greater than 100,000 mm-3. Written informed consent was obtained prior to entry on the study. The common toxicity scale was used to grade toxicity.Twenty-six patients were entered. All were evaluable for toxicity. While 21 are evaluable for response on the basis of having either a lesion measurable on physical exam or radiographic study or at subsequent laparotomy. Five patients did not have measurable disease upon entry onto the study. A total of 91 evaluable courses were administered to these patients. Twenty-one patients were female and five were male. The median age was 59 with a range from 26 to 83. ECOG performance status ranged from 0 to 2. Eighteen patients had ovarian cancer, three had gastric, two had colon, and one each had fallopian tube, pancreas and sarcoma. Nineteen patients had received prior chemotherapy, and seven had received prior radiation therapy. Seventeen patients had received prior cisplatin containing regimens, and eight had received prior intraperitoneal chemotherapy. Six patients (two gastric carcinoma, one pancreatic carcinoma,

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Carboplatin (CBDCA, JM-8) and VP-16-213 in previously untreated patients with small-cell lung cancer.

Cited by 105 publications

References 12 publications

A pilot study of MVP (mitomycin-C, vinblastine and cisplatin) chemotherapy in small-cell lung cancer

A pilot study of MVP (mitomycin-C, vinblastine and cisplatin) chemotherapy in small-cell lung cancer

Randomized Phase II Study of Carboplatin and Etoposide With or Without thebcl-2Antisense Oligonucleotide Oblimersen for Extensive-Stage Small-Cell Lung Cancer: CALGB 30103

A phase I and pharmacokinetic study of intraperitoneal carboplatin and etoposide

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