The cancer registry as an ally in monitoring treatment effectiveness

Costa, Filipa Alves da; Ramos, Catarina; Murteira, Rodrigo; Almodovar, Teresa; Passos‐Coelho, José Luís; Carvalho, Marta; Costa, Luís; Brito, Mariana; Ramos, Sância; Ferreira, M.; Miranda, Ana

doi:10.1016/j.pulmoe.2018.05.007

Cited by 5 publications

(5 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Despite broader inclusion criteria used in EVIDENS, these effectiveness results are in line with those of the CheckMate 017 7 and 057 6 phase III trials and other real-world studies of nivolumab conducted in Europe ( Table 5). [15][16][17][18][19][20][21][22][23][24][25][26][27] Examination of the influence of baseline characteristics on OS did not reveal any significant effect of PD-L1 expression, although the analysis may have been underpowered to detect an association given that the sample size of patients in whom PD-L1 expression data were available was small. ECOG PS, smoking status, corticosteroids at baseline, EGFR mutation status, symptomatic brain metastasis and TRAEs significantly influenced OS in nivolumab recipients as seen in our multivariate analysis, even though some of these factors are also well-known prognostic factors in NSCLC.…”

Section: Discussionmentioning

confidence: 99%

“…13 Instead, data have been reported from small patient cohorts, retrospective studies and early access programs, for which inclusion/exclusion enrollment criteria may be restrictive. [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] Due to known variation in cancer survival rates across Europe, 28 country-specific data may be more appropriate to describe the real-world experience with nivolumab in the treatment of NSCLC. Furthermore, data collected in the context of a real-world study can also help to address important clinical evidence gaps such as the outcomes in patients who were underrepresented in, or excluded from, pivotal clinical trials of nivolumab due to more severe comorbidities or poor prognostic factors.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

et al. 2020

View full text Add to dashboard Cite

EVIDENS is an ongoing, prospective, non-interventional study evaluating the effectiveness and safety of nivolumab in lung cancer patients in France (ClinicalTrials.gov NCT03382496).Adults with a pathologically confirmed diagnosis of lung cancer and initiating treatment with nivolumab were recruited from 146 sites in France. This analysis included only patients with non-small cell lung cancer (NSCLC) who received ≥1 nivolumab infusion, and evaluated patient characteristics at the time of nivolumab initiation and its effectiveness and safety after a median follow-up of 18 months.A total of 1,420 patients with NSCLC were included, most of whom had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 (82.9%), non-squamous histology (69.2%) and stage IV disease (91.4%). Brain metastases were present in 19.9% of patients. Nivolumab was a secondline or ≥third-line regimen in 73.6% and 26.1% of patients, respectively. Almost all patients had prior chemotherapy (99.7%). Median overall survival was 11.2 months (95% confidence interval [CI]: 10.0--12.4). ECOG PS, smoking status, corticosteroids at baseline, epidermal growth factor receptor mutation status, presence of symptomatic brain metastases and treatment-related adverse events (TRAEs) were independent predictors of survival. Grade 3 and 4 TRAEs were reported in 105 (7.4%) and 12 (0.8%) patients, respectively; no treatment-related deaths were reported.Preliminary results of the EVIDENS study confirm the effectiveness and safety of nivolumab, mostly in pre-treated advanced NSCLC patients, with similar benefits to those observed in the phase III randomized clinical trials, despite a broader study population. ARTICLE HISTORY

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

et al. 2020

View full text Add to dashboard Cite

show abstract

“…In lung cancer, it is licensed for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Two large randomised studies in patients with advanced non-squamous (NSq) NSCLC (CheckMate057 [3]) and squamous (Sq) NSCLC (CheckMate017 [4]) comparing nivolumab to docetaxel have demonstrated its efficacy at extending overall survival (OS) [5,6], and the interest of nivolumab in treating NSCLC has been confirmed in many subsequent studies in routine clinical practice [7][8][9][10][11][12][13][14][15][16][17][18].…”

Section: Introductionmentioning

confidence: 99%

Immunotherapy rechallenge after nivolumab treatment in advanced non-small cell lung cancer in the real-world setting: A national data base analysis

Levra¹,

Cotté²,

Corre³

et al. 2020

Lung Cancer

View full text Add to dashboard Cite

Nivolumab is now a reference treatment for patients with advanced non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy. Little data are available on treatment approaches following discontinuation of nivolumab and on the interest of a second course of immunotherapy after nivolumab discontinuation. The aims of this study were to describe treatment pathways following nivolumab discontinuation and to describe survival following retreatment with immunotherapy. Materials and methods: The analysis includes all patients with NSCLC recorded in a national hospital database, starting nivolumab in 2015-2016. Nivolumab treatment was considered discontinued if ≥3 infusions were missed. Patients starting a second course of PD-1 inhibitor following nivolumab discontinuation were analysed according to the duration of their initial nivolumab treatment course. Results: 10,452 patients were included (71 % men; mean age: 63.8 ± 9.6 years; squamous histology: 44 %). Median nivolumab treatment duration was 2.8 months [IQR :1.4-6.9]. Median OS was 11.5 months [95 %CI: 11.1-11.9]; 5118 (53.4 %) patients received post nivolumab therapy lines: 1517 (29.6 %) of these received a second course of PD-1 inhibitor, either after a treatment-free interval (resumption: n = 1127) or after intervening chemotherapy (rechallenge: n = 390). Median OS after nivolumab discontinuation was 15.0 months [13.9-16.7] in the resumption group and 18.4 months [14.8-21.9] in the rechallenge group. Median OS was significantly longer in patients with an initial nivolumab treatment duration ≥3 months. Conclusion: In this real-world setting, outcome after retreatment with a PD-1 inhibitor following a first course of nivolumab was significantly better in patients with a longer duration of initial nivolumab treatment.

show abstract

“…is a valid source of information which may be used to provide additional information to the regulator. 8 In fact, this study showed a very narrow efficacy-effectiveness gap (OS = 12.2 months versus 11.4 months), supporting full licensing of nivolumab.…”

Section: Medicines Financingmentioning

confidence: 58%

“…Its effectiveness was evaluated through close monitoring of an inception cohort of 115 patients distributed throughout the country. Published data clearly demonstrate that cancer registry is a valid source of information which may be used to provide additional information to the regulator . In fact, this study showed a very narrow efficacy‐effectiveness gap (OS = 12.2 months versus 11.4 months), supporting full licensing of nivolumab.…”

Section: Medicines Financingmentioning

confidence: 64%

Using cancer registries to supplement clinical trial data and inform regulatory decision

Costa

Miranda

2019

Pharmacoepidemiology and Drug

View full text Add to dashboard Cite

The cancer registry as an ally in monitoring treatment effectiveness

Cited by 5 publications

References 5 publications

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

Immunotherapy rechallenge after nivolumab treatment in advanced non-small cell lung cancer in the real-world setting: A national data base analysis

Using cancer registries to supplement clinical trial data and inform regulatory decision

Contact Info

Product

Resources

About