Since the publication of this article, the authors have become aware that the death of one patient in the cisplatin-pemetrexed-erlotinib (CPE) arm of the study was incorrectly processed in the data analyses, and not counted towards progression-free survival (PFS) and overall survival (OS). As a result, the OS and PFS estimates in the published article are incorrect.
No other data (patient characteristics, duration of response, time on treatment, adverse events, etc.) were affected by the programming error, which only concerned one death.
The main conclusion of the article, that “this study supports the hypothesis that CPE has a longer PFS than erlotinib monotherapy, but the combination of intercalated erlotinib with cisplatin and pemetrexed is not favourable over erlotinib alone, due to toxicity” still stands.
The following corrections have been made in the article itself.
In the abstract:
“Median PFS was 13.7 months (95% CI 5.2–18.8) for CPE and 10.3 months (95% CI 7.1–15.5; hazard ratio (HR) 0.62, 95% CI 0.25–1.57) for erlotinib monotherapy; when compensating for number of days receiving erlotinib, PFS of the CPE arm was superior (HR 0.24, 95% CI 0.07–0.83; p=0.02). Median overall survival was 31.7 months (95% CI 21.8–61.9 months) for CPE compared to 17.2 months (95% CI 11.5–45.5 months) for erlotinib monotherapy (HR 0.58, 95% CI 0.22–1.41 months).”
has been corrected to:
“Median PFS was 8.8 months (95% CI 4.2–18.8) for CPE and 10.3 months (95% CI 7.1–15.5); hazard ratio (HR) 0.78, (95% CI 0.32−1.91) for erlotinib monotherapy; when compensating for number of days receiving erlotinib, PFS of the CPE arm was superior (HR 0.32, 95% CI 0.1−1.01, p=0.05). Median overall survival was 30.9 months (95% CI 18.5–61.9 months) for CPE compared to 17.2 months (95% CI 11.5–45.5 months) for erlotinib monotherapy (HR 0.66, 95% CI 0.27−1.65).”
In the results section “Tumour response and survival”:
“PFS in patients treated with CPE was 13.7 months (95% CI 5.2–18.8 months) compared to 10.3 months (95% CI 7.1–15.5 months) in those treated with erlotinib monotherapy (unstratified hazard ratio (HR) 0.62, 95% CI 0.25–1.57; p=0.31) (figure 1a). With compensation for the number of days receiving erlotinib, the PFS advantage of the CPE over the erlotinib monotherapy arm became significant (HR 0.24, 95% CI 0.07–0.83; p=0.02).
“Median overall survival for CPE and erlotinib monotherapy was 31.7 months (95% CI 21.8–61.9 months) versus 17.2 months (95% CI 11.5–45.5 months; HR 0.55, 95% CI 0.22–1.41; p=0.21), with a 1-year survival rate of 100% (95% CI 72–100%) for CPE versus 73% (95% CI 39–94%) for erlotinib monotherapy (figure 1b).”
FIGURE 1.
a) Progression-free survival and b) overall survival in months by treatment arm. Data are presented with 95% CI. CPE: cisplatin-pemetrexed-erlotinib; E: erlotinib; HR: hazard ratio; cor: corrected.
has been corrected to:
“PFS in patients treated with CPE was 8.8 months (95% CI 4.2–18.8 months) compared to 10.3 months (95% CI 7.1–15.5 months) in those treated with erlotinib monotherapy (unstratified hazard ratio (HR) 0.78, (95% CI 0.32−1.91), p = 0.58) (figure 1a). With compensation for the number of days receiving erlotinib, the PFS advantage of the CPE over the erlotinib monotherapy arm became more pronounced: HR 0.32, 95% CI 0.1−1.01, p=0.05.
“Median overall survival for CPE and erlotinib monotherapy was 30.9 months (95% CI 18.5–61.9 months) versus 17.2 months (95% CI 11.5–45.5 months; HR 0.66, 95% CI 0.27− 1.65; p=0.38), with a 1-year survival rate of 82% (95% CI 48–98%) for CPE versus 73% (95% CI 39–94%) for erlotinib monotherapy (figure 1b).”
The corrected version of table 2 is show below.
TABLE 2.
Outcome measures by treatment arm
CPE | Erlotinib monotherapy | HR (95% CI) | |
Patients randomised | 11 | 11 | |
PFS months, median (95% CI) | 8.8 (4.2–18.8) | 10.3 (7.1–15.5) | 0.78 (0.32–1.91)# |
Overall survival, median (95% CI) | 30.9 (18.5–61.9) | 17.2 (11.5–45.5) | 0.66 (0.27–1.65) |
1-year overall survival, % (95% CI) | 81.8 (48.2–97.7) | 72.7 (39.0–94.0) | |
ORR, % (95% CI) | 64 (31–89) | 55 (23–83) | |
Complete response | 1 (9) | 1 (9) | |
Partial response | 6 (54) | 5 (46) | |
Stable disease | 4 (36) | 5 (46) | |
Duration of response in months, median (95% CI) | 10.8 (7.3–31.2) | 8.0 (5.5–8.7) | 0.43 (0.12–1.47) |
Data are presented as n or n (%), unless otherwise stated. CPE: cisplatin-pemetrexed-erlotinib; HR: hazard ratio; PFS: progression-fee survival; ORR: overall response rate. #: after compensating for numbers of days receiving erlotinib HR 0.32, 95% CI 0.10–1.01, p=0.05.
The corrected version of figure 1 is shown below.
FIGURE 1 a) Progression-free survival and b) overall survival in months by treatment arm. Data are presented with 95% CI. CPE: cisplatin-pemetrexed-erlotinib; E: erlotinib; HR: hazard ratio; cor: corrected.
The corrected version of figure 1 is shown below.