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That's cool A. Rossi caso clinico prima linea 25 settembre 2010

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  • 1. Caso clinico prima linea
    • Donna, 50 anni ricoverata in U.O. Pneumologia
    • Fumatrice (20 sig/die da 30 anni)
    • PS: 1
    • Sintomi: tosse e dispnea da sforzo
    • Comorbidità: ipertensione ben controllata
  • 2. Caso clinico prima linea
    • RX torace: lesioni nodulari bilaterali
    • EO: linfonodo sopraclaveare destro di circa 2.0 cm
    • TC Total-Body con mdc: tumefazione linfonodale sopraclaveare destra 1.7 cm. Multiple lesioni eteroplasiche polmonari periferiche bilaterali, di cui la maggiore di 3 cm al lobo inferiore di destra, linfoadenopatie mediastiniche e retrocarenali (max 3 cm)
    • PET total body: iperaccumulo a livello della regione sopraclaveare destra (SUV 8.9), delle multiple lesioni polmonari bilaterali (SUV max 12.5), e a livello madiastinico (SUV 10.7)
    cT4 N3 M1a – STADIO IV
  • 3. Caso clinico prima linea
    • Broncoscopia con brushing e BAL: non alterazioni della canalizzazione bilateralmente fino al limite della visione endoscopica, in rapporto all’ubicazione periferica delle lesioni.
    • Brushing: negativo
    • BAL: positivo per carcinoma NOS
  • 4.
    • Per decidere un trattamento di prima linea più appropriato è mandatorio determinare l’istotipo e lo stato mutazionale di EGFR.
    • E’ necessario:
    • asportare il linfonodo sopraclaveare destro oppure
    • effettuare un ago aspirato dello stesso
    • oppure
    • ripetere la broncoscopia con il tentativo
    • di un agobiopsia transbronchiale?
    Caso clinico prima linea: Quesito 1
  • 5. Caso clinico prima linea: Risposta Quesito 1
    • Asportazione linfonodo sopraclaveare destro:
    • adenocarcinoma con EGFR non mutato
  • 6. NSCLC First-line approach in advanced NSCLC EGFR wt or unknown non-squamous squamous ??? ??? ??? consider gefitinib EGFR mut+
  • 7. EGFR-TKIs and EGFR Mutations First-Line Randomized Phase III Studies Study Entry Criteria and Therapy (no.pts) HR for PFS (EGFR mut +) HR for OS (EGFR mut +) IPASS Mok NEJM 2009 Asiatic, never- & light –smokers, adenocarcinoma (EGFR mut + 59.7%) GEF (609) vs. CBDCA+PAC (608) 0.48 (0.36-0.66) 0.91 * (0.76-1.10) *overall population First – SIGNAL Proc. IASLC 2009 Adenocarcinoma, Never-smokers (EGFR mut + 44%) GEF (159) vs. CDDP+GEM (150) 0.61 (0.30-1.22) 0.82 (0.35-1.92) NEJ002 Maemondo NEJM 2010 EGFR Mutation + (all) GEF (98) vs. CBDCA+PAC (96) 0.30 (0.22-0.41) GEF 30.5 mos CT 23.6 mos P = 0.31 WJTOG3405 Mitsudomi Lancet Oncol 2010 EGFR Mutation + (all) GEF (86) vs. CDDP+DOC (86) 0.49 (0.34-0.71) NA EURTAC (EU) EGFR Mutation + (all) ERL vs. Platinum-based chemo ? ongoing ? ongoing OPTIMAL (China) EGFR Mutation + (all) ERL vs. CBDCA+GEM ? ongoing ? ongoing
  • 8.
    • Quale terapia di prima linea?
    • Cisplatino + Pemetrexed
    • Carboplatino + Paclitaxel + Bevacizumab
    • Cisplatino + Gemcitabina + Bevacizumab
    Caso clinico prima linea: Quesito 2
  • 9. JMDB HR 0.81 subset beva-eligible ECOG HR 0.80 AVAiL HR 0.98 NSCLC
    • *Beva-eligible: non-squamous, no gr  2 haemoptysis, no invasion of major vessels,
    • no cavitation, no uncontrolled hypertension, no recent history of thrombosis,
    • no hemorrhagic disorders, no recent anticoagulation
    First-line approach in advanced NSCLC EGFR wt or unknown non-squamous squamous cisplatin- pemetrexed doublet + bevacizumab platinum doublet consider gefitinib EGFR mut+
  • 10. JMDB (ADK)* E4599 (ADK)° AVAiL (NSQ)^ (CDDP+PEM) (CBDCA+PAC+BEV) (CDDP+GEM+BEV) OR (%) PFS (mos) OS (mos) Female OS (NSQ mos) G3/4 Toxicity (%) (NSQ) Neutropenia FN PLT Hypertension Any G Alopecia Outcomes in Adenocarcinoma histology 31.9 35 34.6-37.8 5.5 6.6 6.5-6.7 12.6 14.2 13.4-13.6 13.8 13.3 NR 15.1 25.5 36-40 1.3 5.2 2.0 4.1 1.6 23-27 NR 7.0 6-9 11.9 NR NR 52% (Scagliotti JCO 2002) 10% *Scagliotti JCO 2008; Scagliotti Oncologist 2009 °Sandler NEJM 2006; Sandler JTO 2010 ^Reck JCO 2009; Reck Ann Oncol 2010
  • 11. S130: Pem/Carbo  Pem vs. Pac/Carbo + Bev  Bev Arm B :
    • 360 Randomized Patients
    • Stratification factors:
    • Disease stage
    • Performance status
    • Gender
    R A N D O M I Z E Pemetrexed 500 mg/m 2 Carboplatin AUC 6 q 21 days X 4 cycles* Paclitaxel 200 mg/m 2 Carboplatin AUC 6 Bevacizumab 15 mg/kg q 21 days X 4 cycles* Arm A: Pemetrexed 500 mg/m 2 q 21 days until PD or treatment discontinuation Bevacizumab 15 mg/kg q 21 days until PD or treatment discontinuation *In both treatment arms, patients with CR, PR, or SD after 4 cycles of induction therapy continue on to maintenance therapy. Induction Therapy Maintenance Therapy Zinner R, Saxman S, Peng G, et al. Randomized, Open-Label Study of Pemetrexed/Carboplatin Followed by Maintenance Pemetrexed Versus Paclitaxel/Carboplatin/Bevacizumab Followed by Maintenance Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) of Nonsquamous Histology. ASCO - Chicago, IL, Jun 4-8, 2010 – JCO 28, abstr. TPS290. Primary endpoint: PFS without G4 toxicity, HR=0.75, N=360