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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

Partitioned survival curves for (A) panitumumab+BSC and (B) BSC alone. BSC=best supportive care; REL=relapse period until death or end of follow up; TOX=days with ⩾grade 3 adverse events; TWiST=time without symptoms or toxicity.
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fig1: Partitioned survival curves for (A) panitumumab+BSC and (B) BSC alone. BSC=best supportive care; REL=relapse period until death or end of follow up; TOX=days with ⩾grade 3 adverse events; TWiST=time without symptoms or toxicity.

Mentions: Partitioned survival plots for panitumumab+BSC and BSC alone, restricted to median follow-up, are presented in Figure 1, with the estimated mean duration of each health state shown in Table 2. The mean duration in the TOX state was approximately 3.5 weeks in the panitumumab+BSC group compared with 1.1 weeks for the BSC alone treatment group (P=0.0006); however, patients on panitumumab+BSC spent 13.3 weeks in the TWiST state compared with 8.0 weeks for patients on BSC alone and the difference of 5.3 weeks was statistically significant (P<0.0001). Patients on BSC alone had a longer duration during REL; however, the duration of REL for BSC alone was confounded by the cross-over design of the trial.


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)

Partitioned survival curves for (A) panitumumab+BSC and (B) BSC alone. BSC=best supportive care; REL=relapse period until death or end of follow up; TOX=days with ⩾grade 3 adverse events; TWiST=time without symptoms or toxicity.
© Copyright Policy
Related In: Results  -  Collection

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

fig1: Partitioned survival curves for (A) panitumumab+BSC and (B) BSC alone. BSC=best supportive care; REL=relapse period until death or end of follow up; TOX=days with ⩾grade 3 adverse events; TWiST=time without symptoms or toxicity.
Mentions: Partitioned survival plots for panitumumab+BSC and BSC alone, restricted to median follow-up, are presented in Figure 1, with the estimated mean duration of each health state shown in Table 2. The mean duration in the TOX state was approximately 3.5 weeks in the panitumumab+BSC group compared with 1.1 weeks for the BSC alone treatment group (P=0.0006); however, patients on panitumumab+BSC spent 13.3 weeks in the TWiST state compared with 8.0 weeks for patients on BSC alone and the difference of 5.3 weeks was statistically significant (P<0.0001). Patients on BSC alone had a longer duration during REL; however, the duration of REL for BSC alone was confounded by the cross-over design of the trial.

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