Evidence map›Paper›PMID 33687763›Full record

ReviewThe oncologist2021

FDA Approval Summary: Atezolizumab and Durvalumab in Combination with Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer.

Luckson Mathieu, Sujay Shah, Lee Pai-Scherf, Erin Larkins, Jonathon Vallejo, Xiaoxue Li, Lisa Rodriguez, Pallavi Mishra-Kalyani, Kirsten B Goldberg, Paul G Kluetz and 4 more

Open access · bronzeAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The oncologist, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 104 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
104citing papers in PubMed, 6 pooled it
9.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

104 citing papers in PubMed, 6 syntheses or guidelines pooled it, 141 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Small Cell Lung Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2021
    Guideline
  7. DONSON links tumor-cell survival to MIF-associated macrophage remodeling in small cell lung cancer.Apoptosis : an international journal on programmed cell death · 2026
    Article
  8. Article
  9. Review
  10. Review
  11. Humoral immunity in cancer.Signal transduction and targeted therapy · 2026
    Review
  12. Observational
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Observational

44 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 2 institutions in 1 country.

Luckson MathieuCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Sujay ShahCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Lee Pai-ScherfCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Erin LarkinsCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Jonathon VallejoCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Xiaoxue LiCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Lisa RodriguezCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Pallavi Mishra-KalyaniCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Kirsten B GoldbergOncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Paul G KluetzCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Marc R TheoretCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Julia A BeaverCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Richard PazdurCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Harpreet SinghCenter for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Center for Drug Evaluation and Research · USUnited States Food and Drug Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The U.S. Food and Drug Administration (FDA) granted approval to atezolizumab and durvalumab in March of 2019 and 2020, respectively, for use in combination with chemotherapy for first-line treatment of patients with extensive stage small cell lung cancer. These approvals were based on data from two randomized controlled trials, IMpower133 (atezolizumab) and CASPIAN (durvalumab). Both trials demonstrated an improvement in overall survival (OS) with anti-programmed death ligand 1 antibodies when added to platinum-based chemotherapy as compared with chemotherapy alone. In IMpower133, patients receiving atezolizumab with etoposide and carboplatin demonstrated improved OS (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.54-0.91; p = .0069), with median OS of 12.3 months compared with 10.3 months in patients receiving etoposide and carboplatin. In CASPIAN, patients receiving durvalumab with etoposide and either cisplatin or carboplatin also demonstrated improved OS (HR, 0.73; 95% CI, 0.59-0.91; p = .0047) with median OS of 13.0 months compared with 10.3 months in patients receiving etoposide and either cisplatin or carboplatin. The safety profiles of both drugs were generally consistent with known toxicities of immune-checkpoint inhibitor therapies. This review summarizes the FDA perspective and data supporting the approval of these two agents. IMPLICATIONS FOR PRACTICE: Effective therapeutic options for small cell lung cancer (SCLC) are limited, and there has been modest improvement in the overall survival (OS) of patients with SCLC over the past 3 decades. The approvals of atezolizumab and of durvalumab in combination with chemotherapy for first-line treatment of patients with extensive stage SCLC represent the first approved therapies with OS benefit for this patient population since the approval of etoposide in combination with other approved chemotherapeutic agents. Additionally, the efficacy results from IMpower133 and CASPIAN lay the groundwork for possible further evaluation in other treatment settings in this disease.

Indexed as

Lung NeoplasmsSmall Cell Lung CarcinomaAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHumansPlatinumUnited StatesUnited States Food and Drug AdministrationAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedatezolizumabdurvalumabPlatinumAtezolizumab and durvalumab in small cell lung cancerFDA approval

Identifiers

PMID33687763
PMCPMC8100557
OpenAlexW3134820202

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.