Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non–Small-Cell Lung Cancer

Ramlau, Rodryg; Gervais, Radj; Krzakowski, Maciej; Pawel, Joachim von; Kaukel, E.; Abratt, Raymond P.; Dharan, B.; Grotzinger, Kelly M.; Ross, Graham; Dane, G.; Shepherd, Frances A.

doi:10.1200/jco.2005.03.6491

Cited by 96 publications

(58 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…A randomized phase III trial in 829 patients found that oral topotecan was not inferior to docetaxel. 287 If disease progression occurs after second-or third-line chemotherapy, patients with a PS of 0 to 2 may be treated with best supportive care or be enrolled in a clinical trial. Best supportive care only should be provided to patients with a PS of 3 to 4 and progressive disease during any stage of the treatment (see NCCN Clinical Practice Guidelines in Oncology [NCCN Guidelines] on Palliative Care; to view the most recent version of these guidelines, visit the NCCN Web site at www.NCCN.org).…”

Section: Treatment Of Recurrences and Distant Metastasesmentioning

confidence: 99%

Non–Small Cell Lung Cancer

Ettinger

Akerley

Bepler

et al. 2010

J Natl Compr Canc Netw

604

371

View full text Add to dashboard Cite

show abstract

Section: Treatment Of Recurrences and Distant Metastasesmentioning

confidence: 99%

Non–Small Cell Lung Cancer

Ettinger

Akerley

Bepler

et al. 2010

J Natl Compr Canc Netw

604

371

View full text Add to dashboard Cite

show abstract

“…Docetaxel demonstrated similar activity in squamous and non-squamous patients. While not approved for second-line therapy in Canada, topotecan, vinflunine, and gefitinib have also demonstrated outcomes similar to those with docetaxel in randomized trials [50][51][52] .…”

Section: Second-and Third-line Therapy In Advanced Nsclcmentioning

confidence: 99%

Treatment Paradigms for Patients with Metastatic Non-Small-Cell Lung Cancer: First-, Second-, and Third-Line

Leighl

2012

Current Oncology

117

View full text Add to dashboard Cite

Treatment paradigms for patients with metastatic non-small-cell lung cancer: first-, second-, and third-line Curr Oncol, Vol. 19, pp. S52-S58; doi: http://dx.doi.org/10.3747/co.19.1114 ABSTRACT Metastatic non-small-cell lung cancer (nsclc) is the leading cause of cancer mortality in Canada. Although treatment outcomes in advanced disease remain modest, with paradigm shifts in the approach to treatment, they are steadily improving. Customizing treatment based on histology and molecular typing has become the standard of care. EGFR genotyping and pathology subtyping should be considered routine in new diagnoses of metastatic nsclc. Treatment options for those with somatic EGFR activating mutations include gefitinib until progression, followed by standard chemotherapy. For patients with wild-type EGFR, or in patients whose EGFR genotype is unknown, platinum-based chemotherapy remains the firstline standard, with single-agent chemotherapy as an option for older patients and those who are unfit for platinum-doublet therapy. Patients with nonsquamous histology may receive treatment regimens incorporating pemetrexed or bevacizumab. In patients with squamous cell carcinoma, the latter agents should be avoided because of concerns about enhanced toxicity or decreased efficacy. Secondline chemotherapy is offered to a selected subgroup of patients upon progression and may include pemetrexed in non-squamous histology and docetaxel or erlotinib (or both) in all histologies. Currently, only erlotinib is offered as a third-line option in unselected nsclc patients after failure of first-and second-line chemotherapy. Maintenance therapy is emerging as a new option for patients, as are targeted therapies for particular molecular subtypes of nsclc, such as crizotinib in tumours harbouring the EML4-ALK gene rearrangement. KEY WORDSMetastatic non-small-cell lung cancer, nsclc, advanced, systemic therapy, chemotherapy INTRODUCTIONAt more than 25,000 new cases, lung cancer remains the most commonly diagnosed cancer among Canadians (excluding non-melanoma skin cancer); it also causes the greatest number of cancer-related deaths (more than 20,000 deaths per year) 1 . As well, more than half the Canadians diagnosed with lung cancer present with metastatic disease. Most lung cancer patients, approximately 85%, have non-small-cell lung cancer (nsclc). Of those, approximately 40%-60% have adenocarcinoma histology; 10%-15%, squamous histology; 5%, neuroendocrine histology; and the rest, "not otherwise specified" 2,3 .Survival is short in the setting of advanced nsclc, a median of 4-6 months, and more than 80% patients have multiple severe cancer-related symptoms 4-6 . Systemic therapy, the mainstay of treatment in advanced nsclc, can improve survival by up to 8-12 months in selected patients and can improve symptom control and quality of life in 60%-70% despite treatment toxicity 4,[6][7][8] .Since the year 2000, exciting developments have occurred in the treatment of lung cancer, resulting in a paradigm shift. The approach to lung cancer h...

show abstract

“…Eight trials of firstline chemotherapy (23-29) and 5 trials of second-line The FDA analyzed by the 50% effect retention method independently (11 (7,(30)(31)(32)(33) were published in advanced non-small cell lung cancer (NSCLC; Table 3). Active controls were platinum-doublet regimens in all the trials of firstline chemotherapy and were docetaxel in all the trials of second-line chemotherapy.…”

Section: Review In Selected Cancersmentioning

confidence: 99%

Statistical Issues and Recommendations for Noninferiority Trials in Oncology: A Systematic Review

Tanaka

Kinjo

Kataoka

et al. 2012

Clinical Cancer Research

View full text Add to dashboard Cite

To provide an overview of noninferiority trials in oncology with a special emphasis on methodologic issues, we conducted a systematic review of randomized trials assessing noninferiority of antineoplastic treatments. We identified 72 articles, of which 65 were randomized phase III trials with a single control arm, 3 were factorial phase III trials, and 4 were randomized phase II trials. Forty-six were trials in lung, colorectal, or breast cancer. The quality of reporting was improved chronologically (P < 0.01); the major deficiencies were claims of noninferiority when the results did not meet statistical criteria for noninferiority (7 articles) or when the noninferiority margin was not prespecified (5 articles). Four trials (6%) presented plans for switching from superiority to noninferiority. The analysis populations were intent to treat (ITT) in 52, perprotocol set (PPS) in 6, and both ITT and PPS in 11 trials. Noninferiority margins were set in 68 trials (94%); 1 trial used both of the conventional and effect retention methods, 17 trials used the conventional method, 5 trials used the effect retention method, and in 45 trials, the method was not specified. Some trials used margins that possibly were larger than the assured effects of the active controls. No trials explicitly took into consideration uncertainty in historical data. Two trials (3%) specified 2 values of margins. Our findings highlight critical deficiencies in design and reporting of noninferiority trials. Seven practical recommendations are presented.

show abstract

Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non–Small-Cell Lung Cancer

Abstract: Oral topotecan provides activity in the treatment of relapsed, locally advanced, unresectable NSCLC. Both regimens were well tolerated with differing safety profiles. Topotecan may provide an option for patients who desire an orally available treatment after relapse.

Cited by 96 publications

References 9 publications

Non–Small Cell Lung Cancer

Non–Small Cell Lung Cancer

Treatment Paradigms for Patients with Metastatic Non-Small-Cell Lung Cancer: First-, Second-, and Third-Line

Statistical Issues and Recommendations for Noninferiority Trials in Oncology: A Systematic Review

Contact Info

Product

Resources

About