Lung cancer: diagnosis and management

Diagnosis and staging

The evidence identified at the 4 year review on endobronchial ultrasound (EBUS) has a potential impact on NICE CG121, which advises offering EBUS‑guided transbronchial needle aspiration (TBNA), or endoscopic ultrasound (EUS) guided fine needle aspiration (FNA), or non‑ultrasound‑guided TBNA as the first test for patients with an intermediate probability of mediastinal malignancy. It also advises that combined EBUS and EUS should be considered for initial staging of the mediastinum as an alternative to surgical staging. Topic experts agreed that the recommendation may require stronger wording in the light of the new evidence.

NICE CG121 assessed cost effectiveness on the basis of non‑randomised controlled trial (RCT) data and modelling was used to calculate indicative costs. Topic experts agreed that health economic data from the ASTER study provides RCT evidence to inform an update of the health economic model in the guideline.

Decision: This review question should be updated.

Curative treatment options for patients with NSCLC

The new systematic review evidence on video assisted thoracoscopic surgery (VATS) lobectomy for stage 1 NSCLC indicates that VATS may be superior to thoracotomy in terms of 5 year survival, recurrence, intra‑operative blood loss, chest drainage time, hospital stay and complication incidence. However, thoracotomy may be superior in terms of lymph node sampling.

NICE CG121 does not make recommendations on the use of VATS as a minimally invasive technique for lobectomy, and there is therefore a potential need for a new recommendation in this area. Topic expert feedback indicated that there is sufficient existing evidence to form a recommendation. However, additional topic expert feedback indicated that further research, including the results of the ongoing VIOLET study, may be required to inform this and that publishing a recommendation on the basis of current evidence could potentially prevent recruitment to this trial.

Decision: The review question should be considered for a future update, following publication of the VIOLET study. This study is in the recruiting stage and updating the question now could potentially impact on the recruitment process. The surveillance team will track the findings of the VIOLET study.

Topic expert feedback indicated that there is extensive literature building on prognostic and predictive biomarkers. It was considered an emerging area, but with insufficient evidence to result in new recommendations at this time. Further topic expert feedback emphasised the need for recommendations on epidermal growth factor receptor (EGFR) mutation status testing. These are already available through the related guidance EGFR‑TK mutation testing in adults with locally advanced or metastatic NSCLC (2013) NICE diagnostics guidance DG9.

Decision: This review question should not be updated.

Topic expert feedback indicated that:

The new evidence suggests that gemcitabine plus paclitaxel may have similar efficacy to, and lower toxicity than, combination chemotherapy including a platinum‑based drug. This was considered to have a potential impact on NICE CG121 for patients who are unable to tolerate platinum‑based combination chemotherapy. Further new evidence indicated that docetaxel‑based doublet therapy may be superior to docetaxel monotherapy as a second‑line treatment for advanced NSCLC. This has a potential impact on NICE CG121, which states that docetaxel monotherapy should be considered if second‑line treatment is appropriate.

The collective evidence and clinical feedback indicates that the review question should be updated, potentially to encompass health economic modelling.

Decision: This review question should be updated.

Topic expert feedback confirmed that the NHS Commissioning Board is routinely commissioning Stereotactic Ablative Body Radiotherapy (SABR) for the subset of patients with early stage, inoperable NSCLC, and it is now routinely used for this indication, as set out in the NHS Commissioning Board's Clinical commissioning policy: stereotactic ablative body radiotherapy for non-small-cell lung cancer (adult). It was therefore considered necessary for NICE CG121 to be updated to reflect this.

Further clinical feedback indicated that patient travel and planning costs may be offset by delivering SABR in fewer factions and availability of equipment. Cost was not therefore considered to impede access to SABR.

The collective evidence, clinical feedback and NHS commissioning policy indicate that the recommendations may require updating, to incorporate the use of SABR in inoperable early stage NSCLC and its optimum dosing regimens.

Decision: This review question should be updated.

Treatment of SCLC: First-line treatment for limited‑stage disease SCLC

New systematic review and RCT evidence indicates that thoracic radiotherapy starting in the third cycle of chemotherapy, or after the first 30 days, is non‑inferior to early thoracic radiotherapy in terms of the complete response rate, overall survival and progression free survival, and had a more favourable adverse effect profile. There is a potential impact on NICE CG121 to change to offering radiotherapy in the 3rd cycle or after 30 days to reduce adverse effects. Topic expert feedback indicated that in current clinical practice, thoracic radiotherapy is usually started in the second cycle of chemotherapy for patients with limited disease SCLC. Further topic expert feedback indicated that the timing of starting thoracic radiotherapy may not be as significant as the evidence suggests.

Topic expert feedback indicated that it would be sensible to await the results of the CONVERT trial, which is evaluating once vs twice daily radiotherapy, to update this related aspect of dosing regimen.

Decision: This review question should be updated, potentially following publication of the results of the CONVERT trial. Both the timing of starting thoracic radiotherapy and its daily dosing schedule should be considered. The surveillance team will track the findings of the CONVERT trial.

Treatment of SCLC: First-line treatment for extensive‑stage disease SCLC

Topic expert feedback highlighted new evidence on palliative consolidation thoracic radiotherapy. The new RCT evidence by Slotman et al. (2015) suggests that thoracic radiotherapy following any response to four to six cycles of standard chemotherapy may improve survival outcomes. There is therefore a potential impact on NICE CG121, to extend thoracic radiotherapy to patients with any response to chemotherapy.

Topic expert feedback indicated that this is a very important area and good radiotherapy probably improves both symptoms and intermediate survival rates, so should be considered for inclusion in an update. Topic expert feedback further stated that the RCT provides good evidence and oncologists are already adopting this approach. However, additional topic expert feedback raised concern over the emphasis placed on this single RCT. It was therefore felt that the evidence base in this area should be re‑examined.

Decision: This review question should be updated.

Targeted therapies for NSCLC

There are no recommendations in the guideline on new cytotoxic or biologically targeted agents, which were either not licensed for use in the UK during development of NICE CG121 or were undergoing NICE technology appraisals. Topic experts agreed that there is a need to establish a new area in the guideline to incorporate or cross refer to relevant technology appraisals.

Decision: This review question should be included.

Other clinical areas

We also found new evidence that was not thought to have an effect on current recommendations. This evidence related to:

We did not find any new evidence related to:

For any new evidence relating to published or ongoing NICE technology appraisals, the guideline surveillance review deferred to the technology appraisal decision.

Overall decision

After considering all the new evidence and views of topic experts, we decided that a partial update with modified scope is necessary for this guideline.

See how we made the decision for further information.