Phase I trial of weekly paclitaxel in advanced lung cancer.

Akerley, Wallace; Glantz, Michael; Choy, Hak; Rege, Vishram B.; Sambandam, Sundaresan; Joseph, Paul; Yee, L.; Rodrigues, B.F.; Wingate, Patti; Leone, Louis A.

doi:10.1200/jco.1998.16.1.153

Cited by 103 publications

(55 citation statements)

References 11 publications

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“…Historically, response rates of 10% to 15% are seen when using single agent paclitaxel to treat advanced NSCLC (49,50). In contrast, the clinical benefit rate for matuzumab F paclitaxel in our study cohort was significantly higher (f60%), suggesting an additive or synergistic effect of this drug combination.…”

Section: Discussioncontrasting

confidence: 52%

Molecular determinants of response to matuzumab in combination with paclitaxel for patients with advanced non-small cell lung cancer

Schittenhelm

Kollmannsberger

Oechsle

et al. 2009

Molecular Cancer Therapeutics

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Antibodies targeting epidermal growth factor receptor (EGFR) have proven to be effective in patients with nonsmall cell lung cancer (NSCLC) that express EGFR. We recently published a phase I study of weekly matuzumab plus paclitaxel. This therapy was well tolerated and showed clinical responses in the majority of patients. Although matuzumab displays potent antitumor activity in some patients, not all patients respond well to treatment. Whether dysregulation of EGFR-mediated pathways precludes or sensitizes cells to paclitaxel is unknown. We sought to determine molecular predictive factors for therapy response in a phase

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Section: Discussioncontrasting

confidence: 52%

Molecular determinants of response to matuzumab in combination with paclitaxel for patients with advanced non-small cell lung cancer

Schittenhelm

Kollmannsberger

Oechsle

et al. 2009

Molecular Cancer Therapeutics

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“…Furthermore, the performance and staging statuses of the study population predicted a major part of the treatment results: the better the performance status and staging status of the study population, the better the response rate and the survival, and also the less severe the treatment toxicities. Weekly paclitaxel treatment has been found to have a higher response rate and better toxicity profiles in many phase II studies of both chemonaïve patients and patients who have failed previous chemotherapy (Akerley et al, 1998;Belani, 2001;Chang et al, 2001;Koumakis et al, 2002). However, there has been no randomised trial comparing weekly paclitaxel plus cisplatin vs other new anticancer drugs plus cisplatin.…”

Section: Discussionmentioning

confidence: 99%

“…Thus, we performed this phase II randomised trial. The weekly dose of paclitaxel single-agent treatment given to the patient can be 90 mg m À2 or higher (with/ without carboplatin or concomitant radiotherapy) (Belani, 2001;Chang et al, 2001;Koumakis et al, 2002), even up to 175 mg m À2 week À1 for 6 of 8 weeks (Akerley et al, 1998). However, there has been no report of a weekly dose of paclitaxel in combination with cisplatin.…”

Section: Discussionmentioning

confidence: 99%

“…The dosage and schedule of the paclitaxel used varied widely among the different studies and, thus, probably had different therapeutic effects on the patients. In contrast to the conventional paclitaxel treatment schedule of once every 3 or 4 weeks, weekly paclitaxel treatment was found to have a higher response rate and better toxicity profiles in phase II trials of both chemonaïve patients and patients who had failed previous chemotherapy (Akerley et al, 1998;Belani, 2001;Chang et al, 2001;Koumakis et al, 2002). However, there has been no report of randomised phase II or III trials comparing weekly paclitaxel with other new anticancer drugs.…”

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confidence: 96%

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A randomised phase II study of weekly paclitaxel or vinorelbine in combination with cisplatin against inoperable non-small-cell lung cancer previously untreated

Shih

et al. 2004

Br J Cancer

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Phase II studies have suggested that weekly paclitaxel has a higher response rate and better toxicity profile than the conventional schedule of once every 3 or 4 weeks. Our aim was to evaluate the efficacy of weekly paclitaxel plus cisplatin (PC) vs vinorelbine plus cisplatin (VC) in chemonaïve non-small-cell lung cancer (NSCLC) patients. From October 2000 to May 2002, 140 patients were enrolled. The treatment dose was P 66 mg m À2 intravenous infusion (i.v.) on days 1, 8, and 15, and C 60 mg m À2 i.v. on day 15, or V 23 mg m À2 i.v. on days 1, 8, and 15, and C 60 mg m À2 i.v. on day 15, every 4 weeks. In all, 281 cycles of PC and 307 cycles of VC were given to the patients in the PC and VC arms, respectively. There were 26 partial responses and one complete response (overall 38.6%) in the PC arm, and no complete responses, but 27 partial responses (overall 38.6%) in the VC arm. Myelosuppression was more common in the VC arm (Po0.001). Peripheral neuropathy and myalgia were significantly more common in the PC arm (Po0.001). The median time to disease progression was 6 months in the PC arm and 8.4 months in the VC arm (P ¼ 0.0344). The median survival time was 11.7 months in the PC arm and 15.4 months in the VC arm (P ¼ 0.297). We concluded that weekly PC is not suggested for NSCLC patients due to the relatively shorter progression-free survival and more common nonhaematological toxicities.

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“…It has recently been reported that the weekly short-term (1-or 3-hour) administration of paclitaxel may result in a dramatic increase of the dose-density, at a price of a moderate toxicity (Fennelly et al, 1997;Akerley et al, 1998;Sikov et al, 1998).…”

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confidence: 99%

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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Phase I trial of weekly paclitaxel in advanced lung cancer.

Cited by 103 publications

References 11 publications

Molecular determinants of response to matuzumab in combination with paclitaxel for patients with advanced non-small cell lung cancer

Molecular determinants of response to matuzumab in combination with paclitaxel for patients with advanced non-small cell lung cancer

A randomised phase II study of weekly paclitaxel or vinorelbine in combination with cisplatin against inoperable non-small-cell lung cancer previously untreated

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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