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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

(A) Mean quality-adjusted PFS for patients with wild-type KRAS mCRC receiving panitumumab+BSC or BSC alone. (B) Mean quality-adjusted OS for patients with wild-type KRAS mCRC receiving panitumumab+BSC or BSC alone. BSC=best supportive care; mCRC=metastatic colorectal cancer; OS=overall survival; PFS=progression-free survival; Q-TWiST=quality-adjusted time without symptoms of disease or toxicity of treatment.
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fig2: (A) Mean quality-adjusted PFS for patients with wild-type KRAS mCRC receiving panitumumab+BSC or BSC alone. (B) Mean quality-adjusted OS for patients with wild-type KRAS mCRC receiving panitumumab+BSC or BSC alone. BSC=best supportive care; mCRC=metastatic colorectal cancer; OS=overall survival; PFS=progression-free survival; Q-TWiST=quality-adjusted time without symptoms of disease or toxicity of treatment.

Mentions: Applying the utility values from Table 1 to the duration of the TOX and TWiST states, the quality-adjusted difference between groups in PFS was 6.5 weeks favouring panitumumab+BSC over BSC alone (12.3 vs 5.8 weeks, respectively), which was statistically significant (P<0.0001) (Figure 2). Following incorporation of the REL state into the calculation, overall Q-TWiST was 18.2 weeks for panitumumab+BSC compared with 16.1 weeks for BSC alone. Despite the fact that the duration of the REL state was confounded by the significant degree of cross-over to panitumumab after disease progression in those patients randomised to BSC alone arm, the difference in Q-TWiST between groups (panitumumab+BSC vs BSC alone) was statistically significant (P=0.0303) with a point estimate of 2.1 weeks.


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)

(A) Mean quality-adjusted PFS for patients with wild-type KRAS mCRC receiving panitumumab+BSC or BSC alone. (B) Mean quality-adjusted OS for patients with wild-type KRAS mCRC receiving panitumumab+BSC or BSC alone. BSC=best supportive care; mCRC=metastatic colorectal cancer; OS=overall survival; PFS=progression-free survival; Q-TWiST=quality-adjusted time without symptoms of disease or toxicity of treatment.
© Copyright Policy
Related In: Results  -  Collection

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

fig2: (A) Mean quality-adjusted PFS for patients with wild-type KRAS mCRC receiving panitumumab+BSC or BSC alone. (B) Mean quality-adjusted OS for patients with wild-type KRAS mCRC receiving panitumumab+BSC or BSC alone. BSC=best supportive care; mCRC=metastatic colorectal cancer; OS=overall survival; PFS=progression-free survival; Q-TWiST=quality-adjusted time without symptoms of disease or toxicity of treatment.
Mentions: Applying the utility values from Table 1 to the duration of the TOX and TWiST states, the quality-adjusted difference between groups in PFS was 6.5 weeks favouring panitumumab+BSC over BSC alone (12.3 vs 5.8 weeks, respectively), which was statistically significant (P<0.0001) (Figure 2). Following incorporation of the REL state into the calculation, overall Q-TWiST was 18.2 weeks for panitumumab+BSC compared with 16.1 weeks for BSC alone. Despite the fact that the duration of the REL state was confounded by the significant degree of cross-over to panitumumab after disease progression in those patients randomised to BSC alone arm, the difference in Q-TWiST between groups (panitumumab+BSC vs BSC alone) was statistically significant (P=0.0303) with a point estimate of 2.1 weeks.

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