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. Author manuscript; available in PMC: 2023 Feb 13.
Published before final editing as: J Natl Compr Canc Netw. 2021 Aug 13:jnccn20450. doi: 10.6004/jnccn.2021.7021

Table 2.

NSCLC Minimum Measure Set and Harmonized Definitions

OMF Category Outcome Measure Definition

Survival Overall survival Overall survival (collect date of diagnosis and cause of death, if available).

Survival 30-d mortality All deaths within 30 days of treatment (surgery, radiation, or systemic treatment).

Survival Progression-free/disease-free survival Progression-free/disease-free survival, where feasible (see definition of progression and recurrence in “Clinical Response,” below).

Clinical response Progression and recurrence Progression and recurrence should be measured using RECIST (see below) OR clinician documentation of progression/recurrence OR change in therapy due to progression/recurrence.
RECIST guideline13 definition of progressive disease:
 • At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
 • The appearance of one or more new lesions is also considered progression.
Notes:
 • RECIST cannot be used to measure radiated lesions.
 • The sites and numbers of metastases must be captured.
 • The date of progression, defined as the date of the source documentation recording progression or change in lesion, must be captured.
The above is a brief summary of RECIST 1.1. The actual cited document governs the actual decisions regarding radiologic response or progression, including special considerations for lymph nodes as target lesions. In addition, RECIST 1.1 does not consider symptomatic deterioration or other aspects of clinical progression.
Further work is needed to recommend a consistent approach to evaluation of radiated lesions.
Future efforts may also consider use of iRECIST in the context of immunotherapies, although pseudo-progression is sufficiently rare that a separate measure is not recommended for the minimum measure set.

Clinical response Change in performance status Change in performance status, as measured using the ECOG performance status or the Karnofsky performance scale index.

Events of interest Toxicity: major complications Major complications:
 • Surgical complications, defined as one or more of the following:
  ► Pneumonia
  ► Acute respiratory distress syndrome
  ► Bronchopleural fistula
  ► Pulmonary embolus
  ► Initial ventilator support >48 h
  ► Reintubation/Respiratory failure
  ► Tracheotomy
  ► Myocardial infarction
  ► Unexpected return to operating room (any cause)
 • Radiation therapy complications:
  ► CTCAE grade 3 or 4 complications due to radiotherapy
 • Systemic therapy complications:
  ► CTCAE grade 3 or 4 complications due to systemic therapy

Events of interest Toxicity: other complications Other complications:
 • Complications that do not meet the definition of major complications that resulted in change in treatment, change in dose, or schedule delay.

PRO Collection of PROs that capture at least some of the important domains using one or more validated instruments is recommended Important domains to consider in collecting PROs are:
 • Symptoms
 • Functioning (cognitive, physical)
 • Role (ability to participate)
 • Toxicity
These domains should be captured, if feasible. However, patient and clinician burden is an important consideration, and registries may elect to collect a subset of these domains. Validated, publicly available PROs with strong psychometric properties should be used to capture these domains. To minimize burden, use of a tool that captures multiple domains is recommended.
Frequency of PRO collection should depend on the stage of disease, treatment modality, and frequency of office visits/patient contact.

Resource utilization Healthcare utilization All resource utilization related to treatment of lung cancer.

Abbreviations: NSCLC, non–small cell lung cancer; OMF, Outcome Measures Framework; PRO, patient-reported outcome.