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A recent phase III randomised trial showed a clear advantage for GEM plus PCX over PCX alone, as first-line treatment of MBC, in time to disease progression, objective response rate and overall survival (Albain et al, 2004).
Secondary endpoints were efficacy (defined as time to progression), objective tumor-response rate (complete response + partial response), disease-control rate (complete response + partial response + stable disease), and overall survival.
A pre-planned retrospective evaluation of HER2 by fluorescence in situ hybridisation identified 86 patients with HER2-positive disease - in this small subgroup, treatment with paclitaxel-lapatinib resulted in a statistically significant improvement in time to disease progression, objective tumour response and clinical benefit rate.
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Secondary objectives included time to progression (TTP), objective response rate, disease control rate, and tivantinib pharmacokinetics.
In the PANERB trial that prospectively treated 32 KRAS wild-type metastatic CRC patients with cetuximab and irinotecan followed by panitumumab monotherapy after progression, an objective response rate of 22%% to panitumumab, including a disease control rate (objective response plus stable disease) of 73%% was observed in 11 patients who had previously responded to cetuximab and irinotecan [ 10].
The secondary objectives were the determination of the pharmacokinetic profile of scFv FRP5 -ETA, the time to progrescFv FRP5 -ETAecthee response ratimecompleto and progressionnd the immunobjectiveresponse to tratement.
Tumours were assessed every 6 weeks until disease progression, and objective responses were evaluated according to the RECIST guidelines (version 1.1).
Solace is taken in the fact (based on one study) that there appears to be an 8-year gap between evidence of biochemical progression and objective metastatic disease.
A comparison between patients experiencing VTE and patients not experiencing VTE was performed for time to progression and objective response rate.
Secondary endpoints included time to progression (TTP), objective response rate (ORR), and disease control rate based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) and safety.
Data from patients treated with regorafenib after "cross-over" will be analyzed (activity – PFS, Time to progression, best objective response, PFR3 and PFR6, OS- and tolerance) with classical descriptive methods.
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CEO of Professional Science Editing for Scientists @ prosciediting.com