ESMO Clinical Practice Guidelines:

Consensus Conference (CC) SOP

Edited by EDC-SC

September 2013

2

Consensus Conference Membership

Proposal and rationale for Consensus Conference (CC) by Subject Editor (SE) to ESMO

Guidelines Working Group (GLWG), approved by ESMO Educational Steering

Committee (EDC-SC)

One chair nominated by SE, the SE being the co-chair. Validation by GLWG & EDC-SC

Up to 30 members providing pan-European representation, priority to ESMO Faculty

members. Maximum of 4 non-Europeans if they bring scientific expertise.

Acknowledged experts in the field

Multidisciplinary experts as individual professionals.

Declarations of conflict of interest (COI) must be obtained from all invited contributors

before confirmation of their involvement (Responsibility of the chairs)

3

Basic Methodology: Pre-conference

CC Chairs break the Guideline Topic into several subtopics, each containing specific Questions to be addressed within each subtopic. The target audience is physicians practicing in the field of oncology.

Each subtopic is assigned to a Working Group (3-10 members of the CC). For each Working Group (WG) a WG Coordinator will be appointed by the CC Chairs.

A pre-meeting (1 day) must be organized between CC Chairs and the WG Coordinators to work on the Questions of each subtopic. This meeting must take place preferably 6 months prior and at least 3 months prior to the consensus conference.

4

Basic Methodology: Pre-conference

PREPARATION MEETING:

During the preparation meeting the Chairs & WG Coordinators will select the participants to be invited to the Consensus Conference.

At this meeting Questions will be defined to be addressed by each WG.

Following the preparation meeting participants will be invited to join a specific WG and contribute to the preparatory work of the CC.

WGs organize preparatory workshops/meetings in order to work on the subtopic assigned and the developed Questions: via exchange of e-mails, e-meetings, e-processing of a document (MyESMO, Skype, etc). It is likely that no funding for formal physical meetings will be available.

5

CGC Structure

6

Basic Methodology: Pre-conference

Working Group (WG) responsibilities:

Identification of available evidence via a narrative review of the

evidence. The WG Coordinators will decide how the group will

work and may assign specific tasks to each WG member.

Study of relevant evidence (e.g. assign Questions to WG members

who perform narrative review of the evidence).

Writing up of a report on the Questions & evidence review

including a list of important references.

Forwarding of report to Chairs prior to the Consensus Conference.

7

Basic Methodology: Conference

The Chairs are responsible for and have authority over the conference.

Suggested general outline (2 day conference):

INTRODUCTION with all participants.

WG DISCUSSION PHASE: Each WG to convene and discuss the subtopic.

JOINT PRESENTATION PHASE: All members meet for presentation of all WG SoERs, to be critically analyzed & discussed by all.

CONCLUSION PHASE: The CC Chairs conclude what has been discussed, agreed upon or disagreed.

SUMMARY & PLANNING MEETING: The CC Chairs and WG Chairs may spend some additional time at the end of the conference to discuss decisions and next steps.

It is advisable to record areas of dissent.

Following the Consensus Conference, all WGs should send their draft subtopic manuscripts (with Questions, Recommendations and Levels of Evidence) to the Chairs within 1 month.

8

Basic Methodology: Post-Conference

Chairs incorporate all draft subtopic manuscripts (with Questions,

Recommendations and Levels of Evidence) in a pre-final

manuscript.

Areas of controversy and dissent are included and acknowledged in

the final text. Levels of Evidence and references are provided for

every formulated recommendation throughout the document. The

grading system must be consistent across guidelines and the basis

for the class of recommendation & levels of evidence documented.

The pre-final manuscript is circulated to all members of the CC for a

final check and comments/suggestions. The Chairs finalize the

document and forward it to the GLWG and EDC-SC for approval.

9

First-line metastatic non-small-cell lung cancer (Chair: C. Gridelli, participants in this working group: B. Besse, D. Gandara, F. de Marinis, J.P. van Meerbeeck, L. Paz-Ares, R. Pirker, M. Reck, E.F. Smit)

Lung cancer is the most common cancer in the world and the leading cause of cancer-related deaths worldwide with about 1.35 million new diagnoses and 1.18 million deaths worldwide in 2002 [36]. Every year, in Europe, more than 200,000 new cancer cases are diagnosed, accounting for about 20% of all cancer deaths [37]. Non-small-cell lung cancer, including adenocarcinoma, squamous carcinoma and large-cell carcinoma, make up more than 80-85% of all lung cancer types with approximately 70% of patients presenting with advanced disease at diagnosis. The majority of people diagnosed with NSCLC are unsuitable for curative treatment due to advanced disease, thus systemic therapy is the standard approach with palliation, patients’ quality of life (QOL) and prolongation of life being the goal of therapy.

1. Should first-line chemotherapy be offered to all patients with advanced NSCLC?

First-line chemotherapy is shown to be effective in advanced NSCLC patients with PS 0-2 in trials comparing platinum-based chemotherapy or even single-agent chemotherapy with best supportive care (BSC) [38].

Recommendation 1: first-line chemotherapy should be offered to patients with advanced NSCLC and PS 0-2

Strength of recommendation: A

Level of evidence: I

2. Should we start first-line chemotherapy in asymptomatic stable patients with advanced NSCLC immediately or at occurrence/ progression of symptoms?

The survival benefit achieved by palliative chemotherapy in asymptomatic patients with advanced NSCLC is of the same magnitude as in symptomatic ones [38]. Furthermore, QOL either was not worse or improved for those patients receiving chemotherapy in eight clinical trials, four with platinum-based and four with single-agent third-generation drugs [39].

Although not less effective, delaying palliative chemotherapy until symptomatic progression may result in shorter time to progression, worsening of QOL and less drug exposure, all of which are potentially detrimental to outcome [40].

Recommendation 2: the administration of first-line chemotherapy should be offered at diagnosis to asymptomatic patients with advanced NSCLC

Strength of recommendation: C

Level of evidence: III

Levels of Evidence

10

I Evidence from at least one large randomized control trial of good methodological quality (low potential for bias) or meta-analyses of well-conducted randomized trials without heterogeneity

II Small randomized trials or large randomized trials with a suspicion of bias (lower methodological quality) or meta-analyses of such trials or of trials demonstrated heterogeneity

III Prospective cohort studies IV Retrospective cohort studies or case-control studies V Studies without control group, case reports, experts opinions

Grades of Recommendation

11

A Strong evidence for efficacy with a substantial clinical benefit, strongly recommended

B Strong or moderate evidence for efficacy but with a limited clinical benefit, generally recommended

C Insufficient evidence for efficacy or benefit does not outweigh the risk or the disadvantages (adverse events, costs,..), optional

D Moderate evidence against efficacy or for adverse outcome, generally not recommended

E Strong evidence against efficacy or for adverse outcome, never recommended

12

Publication

Authorship includes all members of the CC.

All participants will be listed as authors on the manuscript

(Appendix at the end) with the following being listed

before the abstract in this order: Chair, Working Group

chairs (alphabetical), Subject Editor (co-chair).

Only those participating at the consensus conference can

be included as authors, though the Chair has the final

decision.

13

Organisation / funding / update

No funding should originate from the industry in order to safeguard the integrity of the guidelines (only ESMO or professional networks).

No involvement of industry or patient representatives in guideline development.

A yearly minor update may be performed by Chairs & CC members on a case by case basis, by exchange of emails, e-meetings or e-processing of the document. These small updates can be included in the CPGs.

A major update of the CPG will take place via a reiteration of the Consensus Conference cycle every 5 years or when GLWG/CC Chairs/EDC-SC feel that it is mandated by new scientific developments.

14

CGC Flowchart