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Title: | Phase I/II study of concurrent twice-weekly paclitaxel and weekly cisplatin with radiation therapy for stage III non-small cell lung cancer. | Authors: | Rischin D.;Richardson G.;Ball D.L.;Solomon B.;Millward M.;MacManus M.;Michael M.;Wirth A.;O'Kane C.;Muceniekas L.;Ryan G.;Smith J.G. | Institution: | (Solomon, Ball, Smith, MacManus, Michael, Wirth, O'Kane, Ryan, Rischin) Peter MacCallum Cancer Institute, St. Andrews Place, East Melbourne, Vic. 3002, Australia (Richardson, Muceniekas) Monash Medical Centre, Moorabbin, Vic., Australia (Millward) Royal Prince Alfred Hospital, Sydney, NSW, Australia | Issue Date: | 20-Oct-2012 | Copyright year: | 2003 | Publisher: | Elsevier Ireland Ltd (P.O. Box 85, Limerick, Ireland) | Place of publication: | Ireland | Publication information: | Lung Cancer. 41 (3) (pp 353-361), 2003. Date of Publication: 01 Sep 2003. | Abstract: | The optimal chemoradiation regimen for stage III non-small cell lung cancer (NSCLC) has not been determined. In this phase I/II study, the use of twice-weekly paclitaxel concomitant with weekly cisplatin and thoracic radiotherapy (RT) was evaluated. Patients with stage III NSCLC (without pleural effusion or cervical lymphadenopathy) were treated with thoracic RT (60 Gy in 30 fractions over 6 weeks) with concurrent weekly cisplatin 20 mg/m2 and escalating doses of twice-weekly paclitaxel (starting dose of paclitaxel of 20 mg/m2 increased in increments of 5 mg/m2) in successive cohorts of three to six patients until two or more patients experienced dose limiting toxicities (DLTs) at a particular dose level. All patients were planned to be given a further two cycles of consolidation chemotherapy consisting of paclitaxel 175 mg/m2 and carboplatin AUC 5 after completion of RT. Twenty-five patients were enrolled in this study from two institutions. At a dose of paclitaxel 35 mg/m2, two of four treated patients had DLTs (1 grade 3 oesophagitis and pulmonary toxicity; 1 grade 3 oesophagitis and infection). The recommended dose was therefore determined to be 30 mg/m2 and a total of 15 patients were enrolled in an expanded cohort at this level. The overall response rate for all patients was 64% (95% CI: 43-82%). The estimated median survival was 23.6 months with an estimated 1-year and 2-year survival of 72 and 49%, respectively. Paclitaxel can be safely given twice-weekly at a dose of 30 mg/m2 in combination with weekly cisplatin (20 mg/m2) and thoracic RT (60 Gy), and this regimen has significant activity in stage III NSCLC. © 2003 Elsevier Ireland Ltd. All rights reserved. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1016/S0169-5002%2803%2900235-6 | PubMed URL: | 12928126 [http://www.ncbi.nlm.nih.gov/pubmed/?term=12928126] | ISSN: | 0169-5002 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/32772 | Type: | Article | Subjects: | *cisplatin/dt [Drug Therapy] adult aged alopecia/co [Complication] alopecia/si [Side Effect] anemia/co [Complication] anemia/si [Side Effect] anorexia/si [Side Effect] article bleeding/co [Complication] bleeding/si [Side Effect] *cancer chemotherapy *cancer radiotherapy *cancer staging cancer survival clinical article clinical trial controlled clinical trial controlled study diarrhea/si [Side Effect] dose calculation dose response drug safety edema/co [Complication] *cisplatin/ae [Adverse Drug Reaction] *cisplatin/cb [Drug Combination] *cisplatin/do [Drug Dose] *cisplatin/iv [Intravenous Drug Administration] *paclitaxel/ae [Adverse Drug Reaction] *paclitaxel/cb [Drug Combination] *paclitaxel/do [Drug Dose] *paclitaxel/dt [Drug Therapy] *paclitaxel/iv [Intravenous Drug Administration] esophagitis/co [Complication] esophagitis/si [Side Effect] female hiccup/si [Side Effect] human human tissue hyperglycemia/si [Side Effect] infection/si [Side Effect] insomnia/si [Side Effect] lung disease/si [Side Effect] *lung non small cell cancer/dt [Drug Therapy] *lung non small cell cancer/rt [Radiotherapy] lymphadenopathy malaise/si [Side Effect] male multimodality cancer therapy muscle injury/co [Complication] nausea/co [Complication] nausea/si [Side Effect] neuropathy/si [Side Effect] neutropenia/co [Complication] neutropenia/si [Side Effect] phase 1 clinical trial phase 2 clinical trial pleura effusion priority journal radiation dose radiation pneumonia/co [Complication] radiation response thrombocytopenia/co [Complication] thrombocytopenia/si [Side Effect] tinnitus/si [Side Effect] treatment outcome treatment planning vomiting/co [Complication] vomiting/si [Side Effect] antineoplastic agent/ae [Adverse Drug Reaction] antineoplastic agent/cb [Drug Combination] antineoplastic agent/do [Drug Dose] antineoplastic agent/dt [Drug Therapy] antineoplastic agent/iv [Intravenous Drug Administration] carboplatin/ae [Adverse Drug Reaction] carboplatin/cb [Drug Combination] carboplatin/dt [Drug Therapy] radiation response alopecia / complication / side effect anemia / complication / side effect adult anorexia / side effect article bleeding / complication / side effect *cancer chemotherapy *cancer radiotherapy *cancer staging cancer survival clinical article clinical trial controlled clinical trial controlled study diarrhea / side effect dose calculation dose response drug safety edema / complication esophagitis / complication / side effect female hiccup / side effect human human tissue hyperglycemia / side effect infection / side effect insomnia / side effect lung disease / side effect *lung non small cell cancer / *drug therapy / *radiotherapy lymphadenopathy malaise / side effect male multimodality cancer therapy muscle injury / complication nausea / complication / side effect neuropathy / side effect neutropenia / complication / side effect phase 1 clinical trial phase 2 clinical trial pleura effusion priority journal radiation dose radiation pneumonia / complication aged thrombocytopenia / complication / side effect tinnitus / side effect treatment outcome treatment planning vomiting / complication / side effect |
Type of Clinical Study or Trial: | Clinical trial |
Appears in Collections: | Articles |
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