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A Q-TWiST analysis comparing panitumumab plus best supportive care (BSC) with BSC alone in patients with wild-type KRAS metastatic colorectal cancer.

Wang J, Zhao Z, Barber B, Sherrill B, Peeters M, Wiezorek J - Br. J. Cancer (2011)

Bottom Line: Sensitivity analyses were performed in which utility weights (varying from 0 to 1) were applied to time in the TOX and REL health states.There was a significant difference between groups favouring panitumumab+BSC in quality-adjusted PFS (12.3 weeks vs 5.8 weeks, respectively, P<0.0001) and quality-adjusted OS (P=0.0303).In patients with chemo-refractory wild-type KRAS mCRC, panitumumab+BSC significantly improved quality-adjusted survival compared with BSC alone.

View Article: PubMed Central - PubMed

Affiliation: Department of Statistics, RTI Health Solutions, 3040 East Cornwallis Road, Post Office Box 12194, Research Triangle Park, NC 22709-2194, USA.

ABSTRACT

Background: Panitumumab+best supportive care (BSC) significantly improved progression-free survival (PFS) vs BSC alone in patients with chemo-refractory wild-type KRAS metastatic colorectal cancer (mCRC). We applied the quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) analysis to provide an integrated measure of clinical benefit, with the objective of comparing quality-adjusted survival between the two arms. As the trial design allowed patients on BSC alone to receive panitumumab after disease progression, which confounded overall survival (OS), the focus of this analysis was on PFS.

Methods: For each treatment group, the time spent in the toxicity (grade 3 or 4 adverse events; TOX), time without symptoms of disease or toxicity (TWiST), and relapse (after disease progression; REL) states were estimated by the product-limit method, and adjusted using utility weights derived from patient-reported EuroQoL 5-dimensions measures. Sensitivity analyses were performed in which utility weights (varying from 0 to 1) were applied to time in the TOX and REL health states.

Results: There was a significant difference between groups favouring panitumumab+BSC in quality-adjusted PFS (12.3 weeks vs 5.8 weeks, respectively, P<0.0001) and quality-adjusted OS (P=0.0303).

Conclusion: In patients with chemo-refractory wild-type KRAS mCRC, panitumumab+BSC significantly improved quality-adjusted survival compared with BSC alone.

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Related in: MedlinePlus

Threshold utility plot showing differences in Q-TWiST (in weeks) at varying utility levels. Note: Positive numbers indicate a longer duration of Q-TWiST for patients in combination therapy (panitumumab+BSC).
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fig3: Threshold utility plot showing differences in Q-TWiST (in weeks) at varying utility levels. Note: Positive numbers indicate a longer duration of Q-TWiST for patients in combination therapy (panitumumab+BSC).

Mentions: Using varying hypothetical utility weights for both TOX and REL health states, the overall Q-TWiST difference between groups ranged from −1.6 to 7.6 weeks and favoured panitumumab+BSC therapy for 22 of 25 (or 88% of possible value combinations) hypothetical utility levels (Table 3; Figure 3). Results were statistically significant for all TOX utility levels when REL was valued at ⩽0.5 except utility of TOX=0 and REL=0.5.


A Q-TWiST analysis comparing panitumumab plus best supportive care (BSC) with BSC alone in patients with wild-type KRAS metastatic colorectal cancer.

Wang J, Zhao Z, Barber B, Sherrill B, Peeters M, Wiezorek J - Br. J. Cancer (2011)

Threshold utility plot showing differences in Q-TWiST (in weeks) at varying utility levels. Note: Positive numbers indicate a longer duration of Q-TWiST for patients in combination therapy (panitumumab+BSC).
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3111208&req=5

fig3: Threshold utility plot showing differences in Q-TWiST (in weeks) at varying utility levels. Note: Positive numbers indicate a longer duration of Q-TWiST for patients in combination therapy (panitumumab+BSC).
Mentions: Using varying hypothetical utility weights for both TOX and REL health states, the overall Q-TWiST difference between groups ranged from −1.6 to 7.6 weeks and favoured panitumumab+BSC therapy for 22 of 25 (or 88% of possible value combinations) hypothetical utility levels (Table 3; Figure 3). Results were statistically significant for all TOX utility levels when REL was valued at ⩽0.5 except utility of TOX=0 and REL=0.5.

Bottom Line: Sensitivity analyses were performed in which utility weights (varying from 0 to 1) were applied to time in the TOX and REL health states.There was a significant difference between groups favouring panitumumab+BSC in quality-adjusted PFS (12.3 weeks vs 5.8 weeks, respectively, P<0.0001) and quality-adjusted OS (P=0.0303).In patients with chemo-refractory wild-type KRAS mCRC, panitumumab+BSC significantly improved quality-adjusted survival compared with BSC alone.

View Article: PubMed Central - PubMed

Affiliation: Department of Statistics, RTI Health Solutions, 3040 East Cornwallis Road, Post Office Box 12194, Research Triangle Park, NC 22709-2194, USA.

ABSTRACT

Background: Panitumumab+best supportive care (BSC) significantly improved progression-free survival (PFS) vs BSC alone in patients with chemo-refractory wild-type KRAS metastatic colorectal cancer (mCRC). We applied the quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) analysis to provide an integrated measure of clinical benefit, with the objective of comparing quality-adjusted survival between the two arms. As the trial design allowed patients on BSC alone to receive panitumumab after disease progression, which confounded overall survival (OS), the focus of this analysis was on PFS.

Methods: For each treatment group, the time spent in the toxicity (grade 3 or 4 adverse events; TOX), time without symptoms of disease or toxicity (TWiST), and relapse (after disease progression; REL) states were estimated by the product-limit method, and adjusted using utility weights derived from patient-reported EuroQoL 5-dimensions measures. Sensitivity analyses were performed in which utility weights (varying from 0 to 1) were applied to time in the TOX and REL health states.

Results: There was a significant difference between groups favouring panitumumab+BSC in quality-adjusted PFS (12.3 weeks vs 5.8 weeks, respectively, P<0.0001) and quality-adjusted OS (P=0.0303).

Conclusion: In patients with chemo-refractory wild-type KRAS mCRC, panitumumab+BSC significantly improved quality-adjusted survival compared with BSC alone.

Show MeSH
Related in: MedlinePlus