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ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of non-small-cell lung cancer (NSCLC)


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ESMO Minimum Clinical Recommendations for diagnosis,

treatment and follow-up of non-small-cell lung cancer (NSCLC)


. The crude incidence of lung cancer in the European Union is 52.5/100 000 per year, the mortality 48.7/100 000 per year. Among men the rates are 82.5 and 77.0/100 000 per year, among women 23.9 and 22.3/100 000 per year, respectively. NSCLC accounts for 80% of all cases. About 90% of lung cancer mortality among men (and 80% among women) is attributable to smoking.


. Pathological diagnosis should be made according to the

WHO classification from a bronchoscopic, tru-cut or surgi-cal biopsy or fine needle aspiration.

Staging and risk assessment

. Complete history and physical examination, chest X-ray and CT scan of the chest and upper abdomen if local therapy is being considered. Neurologic history and examination (with a CT scan and/or MRI of the brain if results are abnormal).

. Mediastinal lymph node biopsy for operable NSCLC if CT scan shows nodes >1 cm in shortest transverse axis.

. PET scan if warranted in resectable patients.

. Bone scintigraphy, in the presence of bone pain, elevated serum calcium level, or elevated alkaline phosphatase level.

. Biopsy (or MRI or PET scan) to rule out metastatic disease in otherwise potentially resectable patients with an isolated adrenal mass or liver lesion.

. Patients with NSCLC shall be staged according to the

TNM-2002 system and be grouped into the risk categories shown in Table 1.

Treatment of stage I – II disease

. Surgery remains the standard treatment of early stage NSCLC. Adjuvant chemotherapy should be considered [II, A]. Postoperative radiotherapy is not recommended [I, A].

. Curative radiotherapy as a single modality can achieve a

5-year survival rate of up to 40% in selected patients with clinical stage I disease, and should be considered in cases of medically inoperable stage I and II disease.

Treatment of stage III disease

. Preoperative chemotherapy is standard for resectable stage IIIA. In randomized trials the survival of stage IIIA patients

was significantly better with induction chemotherapy plus surgical resection than with resection alone [I, A].

. Platinum-based chemotherapy and thoracic radiotherapy is the standard treatment for locally advanced, unresectable Stage IIIB NSCLC or medically inoperable stage IIIA NSCLC [I, A].

Treatment of stage IV disease

. Platinum-based chemotherapy combined with vinorelbine,

gemcitabine or taxanes prolongs survival, improves quality of life, and controls symptoms in patients with good performance status [I, A].

Second-line chemotherapy

. Second-line chemotherapy (docetaxel, pemetrexate)

improves disease-related symptoms and improves survival in selected patients [II, B].

Response evaluation

. Response evaluation is mandatory after 2 or 3 cycles of

chemotherapy by repetition of the initial radiographic tests.


. The optimal approach to post-treatment management of patients with thoracic malignancies, including the role of radiologic evaluation, is controversial. For patients treated with curative intent, a history and physical examination should be performed every 3 months during the first 2 years, and every 6 months thereafter.

Table 1. Occult carcinoma Tx N0 M0 Stage 0 Tis N0 M0 Stage IA T1 N0 M0 Stage IB T2 N0 M0 Stage IIA T1 N1 M0 Stage IIB T2 N1 M0 T3 N0 M0 Stage IIIA T1, T2 N2 M0 T3 N1, N2 M0 Stage IIIB Any T N3 M0 T4 Any N M0 Stage IV Any T Any N M1

Annals of Oncology 16 (Supplement 1): i28 – i29, 2005 doi:10.1093/annonc/mdi821



Levels of Evidence [I – V] and Grades of Recommendation [A – D] as used by the American Society of Clinical Oncology are given in square brackets. Statements without grading were considered justified standard clinical practice by the expert authors and the ESMO faculty.


1. Greene FL, Balch CM, Fleming ID, et al. In AJCC (American Joint Committee on Cancer) (ed.): Cancer Staging Handbook: TNM Classification of Malignant Tumors, sixth edition. New York: Springer-Verlag 2002.

2. Stewart LA, Pignon JP. Chemotherapy in non-small-cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomized clinical trials. Br Med J 1995; 311: 899 – 909.

3. Rosell R, Go´mez-Codina J, Camps C et al. A randomized trial com-paring preoperative chemotherapy plus surgery with surgery alone in patients with non-small-cell lung cancer. N Engl J Med 1994; 330: 153 – 158.

4. Sause WT, Scott C, Taylor S et al. Preliminary results of a phase III trial in regionally advanced unresectable non-small-cell lung cancer. J Natl Cancer Inst 1995; 87: 198 – 205.

5. The International Adjuvant Lung Cancer Trial Collaborative Group, Arriagada R, Bergman B, Dunant A et al. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med 2004; 350: 351 – 360.

6. Fossella FV, DeVore R, Kerr RN et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced

non-small-cell lung cancer previously treated with platinum-contain-ing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol 2000; 18: 2354 – 2362.

7. Shepherd FA, Dancey J, Ramlau R et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemother-apy. J Clin Oncol 2000; 18: 2095 – 2103.

8. Hanna N, Shepherd FA, Fossella FV et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004; 22: 1589 – 1597.

Coordinating authors for the ESMO Guidelines Task Force: E. Felip1,

R. A. Stahel2& N. Pavlidis3

1Invited author, Hospital Universitario Vall D’Hebron, Barcelona, Spain; 2

Assigned task force member, Division of Oncology, University Hospital, Ra¨mistr. 100, CH-8091 Zu¨rich, Switzerland;3Assigned task force

member, University of Ioannina, Dept. Medical Oncology, 45110 Ioannina, Greece

Approved by the ESMO Guidelines Task Force: February 2002, last update: December 2004.

Correspondence to: ESMO Guidelines Task Force ESMO Head Office

Via La Santa 7 CH-6962 Lugano Switzerland


Table 1. Occult carcinoma Tx N0 M0 Stage 0 Tis N0 M0 Stage IA T1 N0 M0 Stage IB T2 N0 M0 Stage IIA T1 N1 M0 Stage IIB T2 N1 M0 T3 N0 M0 Stage IIIA T1, T2 N2 M0 T3 N1, N2 M0


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