Read on Twitter
Delay/extension of pembro-based Rx for advanced NSCLC expected #COVID19. In preprint @medRxiv, our experience with outcomes in patients who received atleast ≥4 cycles and had delays/extensions. Results hypothesis-generating only but may be timely. Details & limitations
#lcsm
#lcsm
Rationale:
The most cost-effective admin freq of pembro in advanced NSCLC is uncertain. Pembro 400 mg q6h approved by EMA based on modeling/simulation https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.3062#
Are delays/extensions in pembro(200mg) based Rx associated with worse survival in real-world? 
The most cost-effective admin freq of pembro in advanced NSCLC is uncertain. Pembro 400 mg q6h approved by EMA based on modeling/simulation https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.3062# Are delays/extensions in pembro(200mg) based Rx associated with worse survival in real-world?
Study Details:
Retrospective study of recurrent/metastatic NSCLC patients who received pembro(200mg) ±chemo for ≥4 cycles in 2 academic centers
2 groups: 1.Non-standard (≥2 extended cycles with interval from prior >3wks ± 3days) 2.Standard (all q3wks or 1 extended cycle)
Retrospective study of recurrent/metastatic NSCLC patients who received pembro(200mg) ±chemo for ≥4 cycles in 2 academic centers 2 groups: 1.Non-standard (≥2 extended cycles with interval from prior >3wks ± 3days) 2.Standard (all q3wks or 1 extended cycle)
Results:
Non-standard, 27 pts (29%) VS Standard, 65 (71%)
Reasons for delays in Non-standard: irAEs (33%), non-irAE medical issues (26%), patient-physician preference (41%)
Non-standard group more likely to have higher PD-L1 TPS, pembro monotherapy & median no. of cycles
Non-standard, 27 pts (29%) VS Standard, 65 (71%) Reasons for delays in Non-standard: irAEs (33%), non-irAE medical issues (26%), patient-physician preference (41%) Non-standard group more likely to have higher PD-L1 TPS, pembro monotherapy & median no. of cycles
Results (cont'd)
Univariate and 6month landmark OS & PFS favored non-standard group
Multivariable analysis after adjustment for confounding variables showed NO statistically significant differences in OS or PFS between two groups
Swimmer’s plot for non-standard grp
Univariate and 6month landmark OS & PFS favored non-standard group Multivariable analysis after adjustment for confounding variables showed NO statistically significant differences in OS or PFS between two groups Swimmer’s plot for non-standard grp
Limitations:
Retrospective (unmeasured bias)
Confounding by indication
Small sample size
Combined pembro monotherapy with pembro+chemo
Excluded patients who received <4 cycles
2 academic centers only
Preprint (currently under peer-review)
Retrospective (unmeasured bias) Confounding by indication Small sample size Combined pembro monotherapy with pembro+chemo Excluded patients who received <4 cycles 2 academic centers only Preprint (currently under peer-review)
Conclusions:
29% advanced NSCLC patients received ≥2 delayed/extended pembro-based cycles in routine practice due to irAEs, medical issues or preference
Within limitations (
), associated with similar survival outcomes vs no delays in those who received ≥4 cycles
29% advanced NSCLC patients received ≥2 delayed/extended pembro-based cycles in routine practice due to irAEs, medical issues or preference Within limitations (), associated with similar survival outcomes vs no delays in those who received ≥4 cycles
Conclusions (cont’d):
Prospective evaluation needed to evaluate extended pembrolizumab dosing regimens in randomized non-inferiority clinical trials.
Thankful to the amazing team @BIDMChealth @ECUBrodySOM & mentors @DrGlenWeiss #PaulWalker #DanielCosta #DeepaRangachari
Prospective evaluation needed to evaluate extended pembrolizumab dosing regimens in randomized non-inferiority clinical trials.Thankful to the amazing team @BIDMChealth @ECUBrodySOM & mentors @DrGlenWeiss #PaulWalker #DanielCosta #DeepaRangachari
This project was completed pre #COVID19 and currently under peer-review at a journal. But seemed timely to share with #lcsm community, while duly acknowledging the many limitations of this study (). Tagging some of the #lcsm experts/mentors for their thoughts and feedback.
). Tagging some of the #lcsm experts/mentors for their thoughts and feedback.
@LeciaSequist @RamalingamMD @DrRoyHerbstYale @HosseinBorghaei @StephenVLiu @teekayowo @CharuAggarwalMD @Annechiangmd @JackWestMD @PatelOncology @CoreyLangerMD @marinagarassino @tmprowell
Thankful to @PaulRWalker4 and @ECUBrodySOM team for this wonderful collaboration. Also adding @DrSteveMartin @JerryAzzoli for thoughts & feedback.
