Gemcitabine in metastatic nasopharyngeal carcinoma of the undifferentiated type

Foo, Kian Fong; Tan, Eng Huat; Leong, S. S.; Wee, Joseph; Tan, Tao; Fong, Kok‐Yong; Koh, Lip Seng; Tai, Bee–Choo; Lian, Lay-Geok; Machin, David

doi:10.1093/annonc/mdf002

Cited by 124 publications

(85 citation statements)

References 15 publications

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“…Based on the response rates and their associated CIs, Foo et al (2002) concluded that gemcitabine has moderately high singleagent activity in NPC of the undifferentiated type whether as a first-line or as a salvage treatment. They comment that, while it appears that those who had prior treatment seemed to respond better to gemcitabine, this can possibly be explained by patient selection.…”

Section: Discussionmentioning

confidence: 99%

A Bayesian re-assessment of two Phase II trials of gemcitabine in metastatic nasopharyngeal cancer

Machin

et al. 2002

Br J Cancer

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The Simon two-stage minimax design is a popular statistical design used in Phase II clinical trials. The analysis of the data arising from the design typically involves the use of frequentist statistics. This paper presents an alternative, Bayesian, approach to the design and analysis of Phase II clinical trials. In particular, we consider how a Bayesian approach could have affected the design, analysis and interpretation of two parallel Phase II trials of the National Cancer Centre Singapore, on the activity of gemcitabine in chemotherapy-naïve and in previously treated patients with metastatic nasopharyngeal carcinoma. We begin by explaining the Bayesian methodology and contrasting it with the frequentist approach. We then carry out a Bayesian analysis of the trial results. The conclusions drawn using the Bayesian approach were in general agreement with those obtained from the frequentist analysis. However they had the advantage of allowing for different and potentially more useful interpretations to be made regarding the trial results, as well as for the incorporation of external sources of information. In particular, using a Bayesian trial design, we were able to take into account the results of the parallel trial results when deciding whether to continue each trial beyond the interim stage.

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Section: Discussionmentioning

confidence: 99%

A Bayesian re-assessment of two Phase II trials of gemcitabine in metastatic nasopharyngeal cancer

Machin

et al. 2002

Br J Cancer

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“…However, the duration of response is short, and median overall survival in these trials was on average approximately one year (range: 11 -25 mo). Two trials of non-platinum based monotherapy (gemcitabine 39 and capecitabine 40 ) were associated with worse overall response rates (28% and 37%, respectively) and similar median overall survival (7.2 and 14 months, respectively). Adding vinorelbine to gemcitabine for patients with platinum-resistant disease yielded an overall response rate of 36% with a median overall survival of 11.9 months 41 .…”

Section: Chemotherapy For Recurrent and Metastatic Diseasementioning

confidence: 98%

Nasopharyngeal Carcinoma: The Role for Chemotherapeutics and Targeted Agents

Knol¹,

King²,

Agulnik³

2012

Head and Neck Cancer

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“…GEM-containing regimens have demonstrated tolerable toxicity profiles and encouraging efficacy in bladder cancer, breast cancer, non-small cell lung cancer and pancreatic cancer (22). GEM-based regimens are also commonly used in metastatic and recurrent NPC (23)(24)(25), and exhibit a moderately high activity with tolerable toxicity profiles in patients with NPC who are resistant to CDDP (26). CDDP is an important component of chemotherapy regimens for NPC.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the efficacy and safety of a neoadjuvant gemcitabine and nedaplatin regimen followed by radiotherapy or concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma

2015

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Abstract. The aim of the present study was to evaluate the efficacy and safety of a neoadjuvant gemcitabine and nedaplatin chemotherapy regimen, followed by concurrent chemoradiotherapy or radiotherapy alone, in locoregionally advanced nasopharyngeal carcinoma (NPC). Eighty-six patients with stage III, IVA or IVB NPC, who received neoadjuvant chemotherapy [gemcitabine, 1,000 mg/m 2 on day 1 (d1) and d5; nedaplatin, 25 mg/m 2 on d 1-3] every 3 weeks for at least two cycles, followed by intensity-modulated radiotherapy every 3 weeks, with or without concurrent nedaplatin (25 mg/m 2 , d1-3) between September 2010 and December 2013, were retrospectively analyzed. By comparing pretreatment and post-treatment MRI images, it was shown that seven patients achieved a complete response (8.5%), while 66 achieved a partial response (80.5%), following completion of neoadjuvant chemotherapy (combined response rate, 89.0%). Grade 3-4 toxicities following neoadjuvant chemotherapy included neutropenia (29.1%), leukopenia (11.6%), liver dysfunction (9.3%), thrombocytopenia (9.3%) and nausea/vomiting (8.1%). The median follow-up was 18 months (range, 5-44 months). The 2-year relapse-free survival, distant metastasis-free survival, progression-free survival and overall survival rates were 96.6, 85.4, 83.3 and 96.1%, respectively. Compared with alternative neoadjuvant chemotherapy regimens in combination with radiotherapy or concurrent chemoradiotherapy, the present gemcitabine and nedaplatin did not provide additional survival benefit and led to a higher frequency of liver dysfunction. Therefore, neoadjuvant gemcitabine and nedaplatin should be used with caution in locoregionally advanced NPC.

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Gemcitabine in metastatic nasopharyngeal carcinoma of the undifferentiated type

Abstract: Gemcitabine has moderate activity in NPC with minimal toxicity, and is also an effective salvage agent for patients who have failed or progressed after treatment with other agents.

Cited by 124 publications

References 15 publications

A Bayesian re-assessment of two Phase II trials of gemcitabine in metastatic nasopharyngeal cancer

A Bayesian re-assessment of two Phase II trials of gemcitabine in metastatic nasopharyngeal cancer

Nasopharyngeal Carcinoma: The Role for Chemotherapeutics and Targeted Agents

Evaluation of the efficacy and safety of a neoadjuvant gemcitabine and nedaplatin regimen followed by radiotherapy or concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma

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