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Dr Simon Brewster, Churchill Hospital, Oxford, UK

ESOU Challenging the EAU Guidelines Debate: Stage 1 Non- seminomatous germ cell tumours of the testis should all be managed by Surveillance. Dr Simon Brewster, Churchill Hospital, Oxford, UK. Introduction.

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Dr Simon Brewster, Churchill Hospital, Oxford, UK

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  1. ESOU Challenging the EAU Guidelines Debate: Stage 1 Non-seminomatous germ cell tumours of the testis should all be managed by Surveillance Dr Simon Brewster, Churchill Hospital, Oxford, UK

  2. Introduction • Primary testicular cancer is the most common malignancy in men aged 25-40 years; 2109/year in UK; • Incidence increasing, affecting 6-10 per 100000 men in Europe; • 90% are germ cell tumours, of which 42% are NSGCT; • Following orchidectomy, 33-50% NSGCT are clinical stage 1 (CS1 = TxN0M0 according to serum markers and CT), of whom 70% are cured by surgery alone; • 30% CS1 NSGCT patients harbour occult metastatic disease and will relapse (Vergouwe, 2003).

  3. Risk factors for CS1 NSGCT relapse • Vascular invasion (VI) by tumour cells in the primary tumour - 48% will relapse with metastatic disease (while 52% will not) • 15% patients without VI will also relapse. • Lymphatic invasion; • Embryonal carcinoma (EC); • Absence of yolk sac tumour; • MIB-1 staining of primary tumour; • VI plus >70% MIB-1 staining plus >50% EC predicts relapse in 64% of patients (Albers, 2003) • EAU 2009 Guidelines favour the use of VI as the best risk factor for relapse.

  4. EAU 2009 Guidelines on post-orchiectomy “risk-adapted” management of CS1 NSGCT • Low-risk cases, defined as pT1 (no VI): SURVEILLANCE 5 years (because 15% will relapse) recommended. • High-risk cases, defined as pT2 (=pT1 with VI), pT3-4, or low-risk cases not suitable for surveillance: in order to reduce risk of relapse, TWO CYCLES OF ADJUVANT CYTOTOXIC CHEMOTHERAPY (BEP) or retroperitoneal lymph node dissection (RPLND) recommended.

  5. Adjuvant chemotherapy in CS1 NSGCT with VI: Outcomes • No randomised level 1 evidence of benefit • 2 cycles of BEP: only 3% of patients relapse, therefore risk reduction is 95%; >99% of patients are cured (MRC: Cullen, 1996; Chevreau, 2004); • 1 cycle of BEP: 3.2% of patients relapse; risk reduction is 90% (Tandstad, 2009)

  6. Toxicity of BEP chemotherapy • Hair loss & Neutropenia 100% • Transient infertility likely: cryopreservation necessary; • Cardiovascular effects: hypertension, Raynaud’s phenomenon, myocardial ischaemia / infarction, CVA; up to 15 years later; x 2-7 increased risk (Meinardi, 2000; Huddart, 2003) • Renal impairment: 20-30% most sub-clinical (Fossa, 2001) • Anxiety and depression; Weight gain (Sangstuern, 2005) • Ototoxicity 23-30% (Strumberg, 2002) • Neuropathy 30% (Strumberg, 2002) • Second cancer development, approx. x1.5 risk

  7. Surveillance in CS1 NSGCT: Outcomes • 88% relapses occur during years 1-2 post-orchiectomy; • Relapses are rarely reported >5 years follow-up; • Evaluations must include clinical examination, serum markers, CXR (5 years) and CT scans (at least 2 years); • Non risk-adapted surveillance: • of 371 patients 1981-2005, 28% overall (52% VI+ve; 16% VI –ve) relapsed; 72% spared further treatment; survival (following salvage BEP +/- RPLND) >99% (Zuniga, Toronto group, 2009); • Of 223 patients, median follow-up 52 months, 26% overall (52% VI+ve; 0% VI –ve) relapsed; 74% spared further treatment; survival 100% (Kollmansgerger, British Columbia group, 2009)

  8. Case history • Mr AH age 28 years, chef, recent move to Oxford • Mixed GCT right testis, 2.6cm lower pole, pT2 • Serum markers and CT scans normal • Underwent 2 cycles BEP over 6 weeks • Cryopreservation undertaken prior to treatment • Family live in Scotland so unable to support him • Became depressed, unable to work for 6 months, no income, fatigued, counselled for stress, unable to concentrate, complained of tinitus, peripheral parasthesia, hair loss and nausea.

  9. ConclusionThe EAU Guideline recommending adjuvant chemotherapy to high-risk CS1 NSGCT patients will result in >50% of these young men being overtreated with cytotoxic drugs, for NO PROVEN SURVIVAL BENEFIT.

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