Evidence map›Paper›PMID 26811176›Full record

ReviewCancer chemotherapy and pharmacology2016

A survey of new oncology drug approvals in the USA from 2010 to 2015: a focus on optimal dose and related postmarketing activities.

Dan Lu, Tong Lu, Mark Stroh, Richard A Graham, Priya Agarwal, Luna Musib, Chi-Chung Li, Bert L Lum, Amita Joshi

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Cancer chemotherapy and pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

24 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

9 authors.

Dan LuDepartment of Clinical Pharmacology, Genentech, Inc., 1 DNA Way, MS 463A, South San Francisco, CA, 94080, USA.
Tong LuDepartment of Clinical Pharmacology, Genentech, Inc., 1 DNA Way, MS 463A, South San Francisco, CA, 94080, USA.
Mark StrohDepartment of Clinical Pharmacology, Genentech, Inc., 1 DNA Way, MS 463A, South San Francisco, CA, 94080, USA.
Richard A GrahamDepartment of Clinical Pharmacology, Theravance Biopharma U.S., Inc., South San Francisco, CA, USA.
Priya AgarwalDepartment of Clinical Pharmacology, Genentech, Inc., 1 DNA Way, MS 463A, South San Francisco, CA, 94080, USA.
Luna MusibDepartment of Clinical Pharmacology, Genentech, Inc., 1 DNA Way, MS 463A, South San Francisco, CA, 94080, USA.
Chi-Chung LiDepartment of Clinical Pharmacology, Genentech, Inc., 1 DNA Way, MS 463A, South San Francisco, CA, 94080, USA.
Bert L LumDepartment of Clinical Pharmacology, Genentech, Inc., 1 DNA Way, MS 463A, South San Francisco, CA, 94080, USA. blum@gene.com.
Amita JoshiDepartment of Clinical Pharmacology, Genentech, Inc., 1 DNA Way, MS 463A, South San Francisco, CA, 94080, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The maximally tolerated dose (MTD) of cytotoxic agents has historical precedence in treating cancer, as it was believed that dose and therapeutic effect are intrinsically linked and that the MTD would provide greatest therapeutic value. With molecularly targeted agents, the premise of preventing toxicity to normal tissues while modulating tumor growth provides a potential for an increased therapeutic window. Results from these targeted agents suggest we are entering an era of chronic cancer management, which will require design of regimens with long-term tolerability. A corresponding switch from MTD-based (toxicity-driven) dosing strategies to alternative paradigms is also expected. The challenge with these targeted agents is to fully understand the complex relationship between pharmacokinetics, pharmacodynamics, and safety and efficacy in early-stage trials, so that the optimal dose and schedule for registration trials may be identified. This review provides a systematic survey of the applications submitted to the United States Food and Drug Administration (FDA) for oncology indications, from 2010 through early 2015, and summarizes the dose selection rationale for registrational trials, the relationship of the MTD to outcomes of the final label dose, the postmarketing requirements or commitments related to dose optimization activities, the role of biomarkers, and typical exposure-response modeling methods.

Indexed as

Drug ApprovalAntineoplastic AgentsDose-Response Relationship, DrugHumansMaximum Tolerated DoseMolecular Targeted TherapyNeoplasmsProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationAntineoplastic AgentsDose selectionFood and Drug AdministrationMaximum tolerated doseModelingOncologyPharmacodynamicsPharmacokinetics

Identifiers

PMID26811176
PMCPMC4767861

What OpenQuestion holds

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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.