Evaluation of Clinical Benefit of Chemotherapy in Patients with Upper Gastrointestinal Cancer

Hoffman, Katarina; Glimelius, Bengt

doi:10.1080/028418698429991

Cited by 23 publications

(4 citation statements)

References 22 publications

(35 reference statements)

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“…In line with the early study by Hoffman and Glimelius [5], CBR reflected mainly physical domains and did not capture the patients' perception of treatment burden. When evaluating a palliative treatment, outcomes complementary to pain, KPS and weight are important: the concept of CBR is too limited to reflect patients' perception.…”

Section: Discussionmentioning

confidence: 52%

“…To our knowledge, the potential confounding of CBR with survival has never been addressed. With a few exceptions [5,6,9], this development has been independent from the establishment of QoL or other patient-rated outcomes (PROs) in cancer clinical trials. In particular, the value of changes in analgesic consumption, KPS, or weight for the evaluation of a palliative treatment, as compared to patients' perception, has not been investigated conclusively.…”

Section: Introductionmentioning

confidence: 99%

“…Furthermore, he questioned whether evaluations based on pain relief and performance status alone reflect a wide-enough range of domains to capture adequately the patients' assessment of their QoL [4]. Hoffman and Glimelius [5] retrospectively applied CBR criteria in 2 randomized trials in upper gastrointestinal cancer and compared them to the physicians' ‘subjective response' evaluation and the patients' standardized QoL assessment. CBR overestimated the beneficial effects in certain patients and underestimated them in others, mainly due to its limitations in reflecting important aspects influencing patients' well-being (e.g.…”

Section: Introductionmentioning

confidence: 99%

“…CBR overestimated the beneficial effects in certain patients and underestimated them in others, mainly due to its limitations in reflecting important aspects influencing patients' well-being (e.g. side effects of chemotherapy, other tumor symptoms) [5]. …”

Section: Introductionmentioning

confidence: 99%

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Clinical Benefit Response in Pancreatic Cancer Trials Revisited

et al. 2014

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Objectives: Clinical benefit response (CBR), based on changes in pain, Karnofsky performance status, and weight, is an established palliative endpoint in trials for advanced gastrointestinal cancer. We investigated whether CBR is associated with survival, and whether CBR reflects a wide-enough range of domains to adequately capture patients' perception. Methods: CBR was prospectively evaluated in an international phase III chemotherapy trial in patients with advanced pancreatic cancer (n = 311) in parallel with patient-reported outcomes (PROs). Results: The median time to treatment failure was 3.4 months (range: 0-6). The majority of the CBRs (n = 39) were noted in patients who received chemotherapy for at least 5 months. Patients with CBR (n = 62) had longer survival than non-responders (n = 182) (hazard ratio = 0.69; 95% confidence interval: 0.51-0.94; p = 0.013). CBR was predicted with a sensitivity and specificity of 77-80% by various combinations of 3 mainly physical PROs. A comparison between the duration of CBR (n = 62, median = 8 months, range = 4-31) and clinically meaningful improvements in the PROs (n = 100-116; medians = 9-11 months, range = 4-24) showed similar intervals. Conclusion: CBR is associated with survival and mainly reflects physical domains. Within phase III chemotherapy trials for advanced gastrointestinal cancer, CBR can be replaced by a PRO evaluation, without losing substantial information but gaining complementary information.

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Section: Discussionmentioning

confidence: 52%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical Benefit Response in Pancreatic Cancer Trials Revisited

et al. 2014

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Chemotherapy for advanced gastric cancer

Wagner

Grothe

Behl

et al. 2005

Cochrane Database of Systematic Reviews

149

151

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Chemotherapy significantly improves survival in comparison to best supportive care. In addition, combination chemotherapy improves survival compared to single-agent 5-FU, but the effect size is much smaller. Among the combination chemotherapy regimens studied, best survival results are achieved with regimens containing 5-FU, anthracyclines and cisplatin. In this category, ECF (epirubicin, cisplatin and continuous infusion 5-FU) is tolerated best.

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Chemotherapy for advanced gastric cancer

Wagner¹,

Unverzagt²,

Grothe³

et al. 2010

Cochrane Database of Systematic Reviews

460

326

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Chemotherapy significantly improves survival in comparison to best supportive care. In addition, combination chemotherapy improves survival compared to single-agent 5-FU. All patients should be tested for their HER-2 status and trastuzumab should be added to a standard fluoropyrimidine/cisplatin regimen in patients with HER-2 positive tumours. Two and three-drug regimens including 5-FU, cisplatin, with or without an anthracycline, as well as irinotecan or docetaxel-containing regimens are reasonable treatment options for HER-2 negative patients.

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Evaluation of Clinical Benefit of Chemotherapy in Patients with Upper Gastrointestinal Cancer

Cited by 23 publications

References 22 publications

Clinical Benefit Response in Pancreatic Cancer Trials Revisited

Clinical Benefit Response in Pancreatic Cancer Trials Revisited

Chemotherapy for advanced gastric cancer

Chemotherapy for advanced gastric cancer

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