Paclitaxel, carboplatin, and extended-schedule etoposide in the treatment of small-cell lung cancer: comparison of sequential phase II trials using different dose-intensities.

Hainsworth, John D.; Gray, James R.; Stroup, Steven L.; Kalman, Leonard; Patten, J E; Hopkins, Lisa G.; Thomas, Michael; Greco, F. Anthony

doi:10.1200/jco.1997.15.12.3464

Cited by 74 publications

(28 citation statements)

References 17 publications

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“…The number of fatal septic episodes was somewhat surprising, because the incidence of Grade 4 leukopenia with this three-drug regimen was not substantially higher than we previously reported with the paclitaxel, carboplatin, and etoposide regimen. 9 In contrast to the current regimen, we observed a treatment-related fatality rate of only 3% in a group of 79 patients with the paclitaxel, carboplatin, and etoposide regimen. In the current trial, most of the treatment-related deaths were observed in patients with a poor performance status (ECOG 2); 5 of 12 patients with a poor performance status who were enrolled in this trial had fatal toxicity.…”

Section: Discussioncontrasting

confidence: 68%

“…This regimen had a high level of activity, with a median survival in patients with extensive stage disease and limited stage disease of 10 months and 25 months, respectively. 9 Early experience with a regimen containing paclitaxel and topotecan also yielded impressive results, including a median survival of 12 months in a small group of patients with extensive stage disease. 10 In a further attempt to incorporate topotecan into first-line combination therapy for patients with small cell lung carcinoma, we performed a Phase I trial to determine the optimum doses of paclitaxel, carboplatin, and topotecan when used in combination.…”

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confidence: 99%

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Paclitaxel, carboplatin, and topotecan in the treatment of patients with small cell lung carcinoma

Hainsworth

Morrissey

Scullin³

et al. 2002

Cancer

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BACKGROUNDThe objective of this study was to evaluate the feasibility, toxicity, and efficacy of a novel three‐drug regimen containing paclitaxel, carboplatin, and topotecan followed by oral etoposide in the first‐line treatment of patients with small cell lung carcinoma.METHODSOne hundred five patients with previously untreated, limited stage or extensive stage small cell lung carcinoma were treated in this multicenter, community‐based, Phase II trial. All patients received paclitaxel 135 mg/m2 by 1‐hour intravenous (IV) infusion on Day 1, carboplatin at an area under the serum concentration‐time curve of 5.0 IV on Day 1, and topotecan 0.75 mg/ m2 IV on Days 1–3. The treatment regimen was repeated at 21‐day intervals for 4 courses. Patients with limited stage disease also received radiation therapy (45 grays [Gy]; in single daily fractions of 1.8 Gy) beginning concurrently with the third course of chemotherapy. Patients who had an objective response or stable disease after 4 courses of combined paclitaxel, carboplatin, and topotecan then received 3 courses of oral etoposide (50 mg alternating with 100 mg for 10 consecutive days) repeated at 21‐day intervals.RESULTSTreatment with paclitaxel, carboplatin, and topotecan produced response rates of 88% and 93% in patients with extensive stage disease and limited stage disease, respectively. The median survival for patients with extensive stage and limited stage disease was 8.3 months and 17.2 months, respectively. The addition of oral etoposide was feasible, but there was no suggestion that it prolonged remission. This three‐ drug regimen was associated with acceptable toxicity in patients with a good performance status, although it was tolerated very poorly by patients with an Eastern Cooperative Oncology Group performance status of 2; 5 of 12 patients (42%) had treatment‐related deaths.CONCLUSIONSAlthough this three‐drug regimen was active in the treatment of patients with small cell lung carcinoma, it was more toxic than standard platinum and etoposide regimens and provided no apparent improvement in efficacy. Further investigation of topotecan as a component of first‐line therapy should focus on two‐drug combination regimens in which the topotecan dose can be optimized. Routine use of three‐drug regimens in patients with small cell lung carcinoma should await demonstration of superiority in randomized trials. Cancer 2002;94:2426–33. © 2002 American Cancer Society.DOI 10.1002/cncr.10508

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confidence: 68%

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confidence: 99%

Paclitaxel, carboplatin, and topotecan in the treatment of patients with small cell lung carcinoma

Hainsworth

Morrissey

Scullin³

et al. 2002

Cancer

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“…Like paclitaxel, carboplatin has radiosensitising properties, which makes the combination of the two drugs with radiotherapy interesting . Hainsworth et al (1997) have investigated the combination of carboplatin, paclitaxel and etoposide in a dose escalation study in 1997. Concurrent TRT was given during cycle 3 and 4 to patients with LS (45 Gy in 25 fractions) and was considered acceptable.…”

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confidence: 99%

Concurrent chemotherapy (carboplatin, paclitaxel, etoposide) and involved-field radiotherapy in limited stage small cell lung cancer: a Dutch multicenter phase II study

Baas

Belderbos

Senan³

et al. 2006

Br J Cancer

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To improve the prognosis of limited stage small cell lung cancer (LS-SCLC) the addition of concurrent thoracic radiotherapy to a platinum-containing regimen is important. In the Netherlands, we initiated a multicenter, phase II study, of the combination of four cycles of carboplatin (AUC 5), paclitaxel (200 mg m À2) and etoposide (2 Â 50 mg orally for 5 days) combined with 45 Gy (daily fractions of 1.8 Gy). The radiation was given to the involved field and concurrently with the second and third chemotherapy cycle. Patients with a partial or complete response received prophylactic cranial irradiation to a dose of 30 Gy. From January 1999 to December 2001, 37 of the 38 patients with LS-SCLC entered were eligible for toxicity analysis and response. Grade 3 and 4 haematological toxicity occurred in 57% (21/37) with febrile neutropenia in 24% (9/37). There were no treatment-related deaths or other grade 4 toxicity. Grade 3 toxicities were oesophagitis (27%), radiation pneumonitis (6%), anorexia (14%), nausea (16%), dyspnea (19%) and lethargy (22%). The objective response rate was 92% (95% confidence interval (CI) 80 -98%) with a median survival time of 19.5 months (95% CI 12.8 -29.2). The 1-, 2-and 5-year survival rate was 70, 47 and 27%, respectively. In field local recurrences occurred in six patients. Distant metastases were observed in 19 patients of which 13 in the brain. This study indicates that combination chemotherapy with concurrent involved-field radiation therapy is an effective treatment for LS-SCLC. Despite PCI, the brain remained the most important site of recurrence.

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“…In two phase II studies it produced an ORR of 34% and 41% in unpretreated patients with extensive disease (Kirshling et al, 1994;Ettinger et al, 1995). It has also been tested in combination with cisplatin (or carboplatin) and etoposide with promising preliminary results (Levitan et al, 1995;Kelly et al, 1996;Hainsworth et al, 1997;Glisson et al, 1999).…”

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A weekly regimen of cisplatin, paclitaxel and topotecan with granulocyte-colony stimulating factor support for patients with extensive disease small cell lung cancer: a phase II study

Frasci¹,

Nicolella²,

Comella³

et al. 2001

Br J Cancer

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The present study was aimed at defining the antitumour activity of the cisplatin-paclitaxel-topotecan (CPT) weekly administration with G-CSF support in chemo-naive SCLC patients with extensive disease (ED-SCLC). Chemonaive ED-SCLC patients received cisplatin 40 mg/m 2 , paclitaxel 85 mg/m 2 , and topotecan 2.25 mg/m 2 weekly, with G-CSF (5 μg/kg days 3–5) support, for a maximum of 12 weeks. 37 patients were treated, for a total of 348 cycles delivered. 8 complete responses (22%) and 22 partial responses (59%) were recorded, giving an 81% [95% CI = 65–92%] ORR. At a 13-month (range, 4–26) median follow-up, median progression-free and overall survival were 8 months and 12.5 months, with 1-year and 2-year projected survivals of 55% and 21%, respectively. No toxic deaths occurred. Grade 4 neutropenia and thrombocytopenia occurred in 6 and 3 patients, respectively. Only one case of neutropenic sepsis was recorded, while haemorrhagic thrombocytopenia was never observed. Diarrhoea, paraesthesias and fatigue were the main nonhaematologic toxicities being severe in 6, 2 and 10 patients, respectively. The weekly CPT combination with G-CSF support represents a well tolerated therapeutic approach in chemo-naive ED-SCLC patients. The activity rate seems at least similar to that achievable with the standard front-line approaches. © 2001 Cancer Research Campaign http://www.bjcancer.com

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Paclitaxel, carboplatin, and extended-schedule etoposide in the treatment of small-cell lung cancer: comparison of sequential phase II trials using different dose-intensities.

Cited by 74 publications

References 17 publications

Paclitaxel, carboplatin, and topotecan in the treatment of patients with small cell lung carcinoma

Paclitaxel, carboplatin, and topotecan in the treatment of patients with small cell lung carcinoma

Concurrent chemotherapy (carboplatin, paclitaxel, etoposide) and involved-field radiotherapy in limited stage small cell lung cancer: a Dutch multicenter phase II study

A weekly regimen of cisplatin, paclitaxel and topotecan with granulocyte-colony stimulating factor support for patients with extensive disease small cell lung cancer: a phase II study

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