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The Impact of Lymphoscintigraphy Technique on the Outcome of Sentinel Node Biopsy in 1,313 Patients with Cutaneous Melanoma: An Italian Multicentric Study (SOLISM–IMI)

¹ Clinica Chirurgica 2, Università di Padova, Padova, Italy; ² Clinical Trials and Biostatistical Unit, Istituto Oncologico Veneto, Padova, Italy; ³ Melanoma Unit, European Institute of Oncology, Milano, Italy; ⁴ Dermatochirurgia, Ospedale Bufalini, Cesena, Italy; ⁵ Dermatochirurgia, Ospedale S. Lazzaro-Molinette, Torino, Italy; ⁶ Clinica Chirurgica, Arcispedale S. Anna, Ferrara, Italy; ⁷ Dermatologia–Dermochirurgia, Ospedale Sestilli, Ancona, Italy; ⁸ Chirurgia Plastica, Università di Bari, Bari, Italy; ⁹ Chirurgia Dermatologica, Istituto Ricerca e Cura del Cancro di Candiolo, Candiolo, Italy; ¹⁰ Medicina Nucleare, Ospedale S. Chiara, Trento, Italy; ¹¹ Divisione di Chirurgia 1, Istituto Regina Elena, Roma, Italy; ¹² Anatomia Patologica, Università di Padova, Padova, Italy; ¹³ Medicina Nucleare 2, Azienda Ospedaliera di Padova, Padova, Italy; and ¹⁴ Chirurgia Plastica e Centro Ustioni, Azienda Ospedaliera di Udine, Udine, Italy; on behalf of the Italian Melanoma Intergroup (IMI)

Correspondence: For correspondence or reprints contact: Carlo Riccardo Rossi, MD, Dipartimento di Scienze Oncologiche e Chirurgiche, Sezione di Clinica Chirurgica, Università di Padova, Via Giustiniani 2, 35128 Padova, Italy. E-mail: carlor.rossi{at}unipd.it

An observational multicentric Italian trial on sentinel node biopsy (SNB) in melanoma patients was performed to diffuse a common SNB protocol nationwide (Italy). We report herein the results of this trial. The influence of some technical aspects on the outcome of SNB was also investigated, because a certain degree of variability was accepted in performing lymphoscintigraphy. Methods: From January 2000 to December 2002, 1,313 consecutive patients with primary cutaneous melanoma (Breslow thickness, >1.0 mm or <1.0 mm but with ulceration, Clark level IV–V, presence of regression) were enrolled by 23 centers. One half to 1 mL of ^99mTc-labeled human albumin colloid, at a suggested dosage of 5–15 or 30–70 MBq, was injected intradermally, closely around the scar, the same day or the day before SNB. Intraoperatively, Patent blue was associated when a definitive wide excision of the primary was required. A positive sentinel node (SN) was defined when containing melanoma cells detected by either hematoxylin–eosin or immunohistochemistry (S100 and HMB45 antibodies). All patients underwent regular follow-up. False-negative cases were considered when lymph node metastases occurred in the same lymphatic basin of SN biopsy (SNB) during follow-up. A quality control program has been performed for the surgical procedure and for the histologic diagnosis. Results: The SN identification rate was 99.3%. The axilla was the site of the SN in 52.5% of the cases. The mean number of SNs was 2.0 (range, 1–17) and only 1 node was removed in 45.4%. The positivity and false-negative rates were 16.9% and 14.7%, respectively (median follow-up, 31 mo). On multivariate analysis (logistic and linear regression) only the number of peritumor injections was inversely associated with the number of excised SNs (P = 0.002), whereas none of the technical variables showed an independent impact on SN status when Breslow thickness was included as a control variable. Conclusion: The number of peritumor injections seems to influence the outcome of lymphoscintigrapy in melanoma patients undergoing SNB. If these results are confirmed in a controlled trial, 3 injections at least should be recommended.

Key Words: lymphoscintigraphy • sentinel node biopsy • cutaneous melanoma • quality control program

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