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NEWSLETTER PTO
WYDANIESPECJALNE PO ASCO
Sobota, 2 lipca 2011 r.
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Szanowni Państwo, Koleżanki i Koledzy
Mam przyjemność przesłać Państwu specjalny numer naszego Newslettera zawierający wykaz najważniejszych doniesień z tegorocznego kongresu Amerykańskiego Towarzystwa Onkologii Klinicznej (ASCO), który odbył się w Chicago w dniach 4-8 czerwca br. Doniesienia zawarte w newsletterze stanowią wybór spośród prac, które zostały przedstawione podczas X Spotkania Po ASCO w Gdańsku 1 i 2 lipca br.
Prezentacje te w wirtualnej wersji będą wkrótce dostępne na stronie internetowej Spotkań Po ASCO:
http://www.poasco.pl/archiwum.php
Jacek Jassem
Przewodniczący Zarządu Głównego
Polskiego Towarzystwa Onkologicznego
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1/ Nowotwory głowy i szyi.
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*5500*
A randomized phase III trial (RTOG 0522) of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III-IV head and neck squamous cell carcinomas (HNC).
K. K. Ang
Conclusions: The addition of cetuximab to the radiation- cisplatin platform did not improve progression-free or overall survival. The triplet regimen was associated with higher rates of mucositis and CET-induced skin reactions but no unexpected toxicity was observed. Whether tumor human papillomavirus status would affect the relative efficacy of the triplet regimen and the overall outcome of this trial is being addressed.
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*5504*
Results of an Ontario Clinical Oncology Group (OCOG) prospective cohort study on the use of FDG PET/CT to predict the need for neck dissection following radiation therapy of head and neck cancer (HNC).
J. N. Waldron
Conclusions: PET/CT performed 8–10 weeks following RT ± Chemo is not a reliable indicator of residual nodal disease and should not be used to determine the need for ND .
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2/ Rak płuca
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*7503*
Erlotinib versus chemotherapy (CT) in advanced non-small cell lung cancer (NSCLC) patients (p) with epidermal growth factor receptor (EGFR) mutations: Interim results of the European Erlotinib Versus Chemotherapy (EURTAC) phase III randomized trial.
R. Rosell
Conclusions: The EURTAC study met its primary endpoint at the interim analysis. Erlotinib as first-line treatment for advanced NSCLC p with EGFR mutations improves PFS, with acceptable toxicity, compared to platinum-based chemotherapy.
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*CRA7510*
PARAMOUNT: Phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced nonsquamous non-small cell lung cancer (NSCLC).
L. G. Paz-Ares
Conclusions: PARAMOUNT met its primary endpoint and showed that pem continuation maintenance following pem-cisplatin induction is an effective and well tolerated treatment for pts with advanced nonsquamous NSCLC.
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*7507*
Impact of crizotinib on survival in patients with advanced, ALK-positive NSCLC compared with historical controls.
A. T. Shaw
Conclusions: In patients with ALK+ NSCLC, crizotinib therapy is associated with a higher OS than that of historical, crizotinib-naïve controls. We propose that crizotinib represents a new standard of care for patients with ALK+ NSCLC.
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3/ Nowotwory przewodu pokarmowego
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*3508*
Overall survival (OS) and updated disease-free survival (DFS) results of the NSABP C-08 trial assessing bevacizumab (B) in stage II and III colon cancer.
C. J. Allegra
Conclusions: The addition of 1 year of B to 6 months of mFF6 does not significantly impact the DFS or OS of patients with stage II and III colon cancer. A transient effect was observed in the experimental arm during B exposure but this did not translate into the prevention of tumor recurrences. The improved DFS prior to the 15-month landmark may be due to growth inhibition of micrometastases and/or effects on tumor vasculature which could impact tumor imaging. This long term followup data from NSABP C-08 does not support the development of a more aggressive cancer phenotype in patients exposed to B.
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*3510*
Final results from PRIME: Randomized phase III study of panitumumab (pmab) with FOLFOX4 for first-line metastatic colorectal cancer (mCRC)
J. Douillard
Conclusions: In pts treated in Arm 1, PFS was improved, ORR was higher, and there was a trend toward improved OS in pts with WT KRAS mCRC, and PFS and OS were reduced in pts with mutant (MT) KRAS mCRC. OS was significantly affected by post-study EGFR inhibitor use. KRAS testing is critical to select appropriate pts for tx with pmab.
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*LBA4002*
Adjuvant capecitabine and oxaliplatin for gastric cancer: Results of the phase III CLASSIC trial.
Y. Bang
Conclusions: This study demonstrates the superior efficacy of adjuvant XELOX vs. observation alone following D2 gastrectomy. Although OS data are still immature, there is a trend towards superiority of XELOX. These data support the use of adjuvant XELOX for GC.
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*LBA4006*
Ampullary cancer ESPAC-3 (v2) trial: A multicenter, international, open-label, randomized controlled phase III trial of adjuvant chemotherapy versus observation in patients with adenocarcinoma of the ampulla of vater J. P. Neoptolemos
J. P. Neoptolemos
Conclusions: This is the only large adjuvant trial ever conducted for ampullary adenocarcinoma. The results suggest a benefit for adjuvant monochemotherapy in patients with clear resection margins.
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4/ Czerniak
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*Video dyskusja:*
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*LBA4*
Phase III randomized, open-label, multicenter trial (BRIM3) comparing BRAF inhibitor RG7204 with dacarbazine in patients with V600EBRAF-mutated melanoma.
P. B. Chapman,
Conclusions: Vemurafenib is associated with significantly improved OS and PFS compared to DTIC in pts with previously untreated, V600EBRAF-mutated metastatic melanoma.
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*LBA5*
Phase III randomized study of ipilimumab (IPI) plus dacarbazine (DTIC) versus DTIC alone as first-line treatment in patients with unresectable stage III or IV melanoma.
J. D. Wolchok
Conclusions: IPI (10 mg/kg) + DTIC significantly improved OS in 1st line metastatic melanoma vs. DTIC alone; durable survival and objective responses were noted in some pts after follow-up for up to 4 yrs. Type of AEs was consistent with prior IPI studies; however, frequencies of some AEs differed with a higher transaminitis and lower diarrhea/colitis/ GI perforation rates than expected. No drug- related deaths were noted in IPI arm. OS benefit of IPI is confirmed in treatment-naive metastatic melanoma.
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5/ Mięsaki
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*LBA1*
Twelve versus 36 months of adjuvant imatinib (IM) as treatment of operable GIST with a high risk of recurrence: Final results of a randomized trial (SSGXVIII/AIO).
H. Joensuu
Conclusions: IM administered for 36 mos improves RFS and OS compared to 12 mos of administration as adjuvant treatment of GIST pts who have a high estimated risk of recurrence after surgery.
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*10017*
An analysis of arterial hypertension and mutational status as predictive factors for results of sunitinib (SU) therapy in gastrointestinal stromal tumors (GIST).
P. Rutkowski
Conclusions: We confirmed that many advanced GIST patients benefit from sunitinib therapy with overall survival exceeding 1.5 year. Primary tumor genotype and SU-induced arterial hypertension (as surrogate of its antiangiogenic activity) are two independent factors influencing the progression-free survival.
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6/ Rak piersi
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*LBA504*
Exemestane for primary prevention of breast cancer in postmenopausal women: NCIC CTG MAP.3 — A randomized, placebo-controlled clinical trial.
P. E. Goss,
Conclusions: Exemestane significantly reduced invasive and pre-invasive breast cancers in postmenopausal women at increased risk for breast cancer with no serious-years of follow-up, 596 contralateral BCs were observed. Overall, the adjusted HR estimates were 0.31 (95% CI: LBA504 toxicities. Exemestane should be considered a new option for primary prevention of breast cancer.
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*506*
Correlation of molecular effects and pathologic complete response to preoperative lapatinib and trastuzumab, separately and combined prior to neoadjuvant breast cancer chemotherapy
F. A. Holmes
Conclusions: Our study provides a unique in vivo snapshot of molecular changes in signaling pathways of microdissected tumor cells before & after anti-HER2 therapy. Molecular profiles suggest NR use autophagy & stem cell related pathways to evade therapy, while R have disruption of HER2-HER3 linkages & known downstream regulators of growth & transcription. These results provide insights into novel candidate “drugable” targets.
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*1501*
Is hormone replacement therapy (HRT) following risk-reducing salpingo-oophorectomy (RRSO) in BRCA1 (B1)- and BRCA2 (B2)-mutation carriers associated with an increased risk of breast cancer?
S. M. Domchek,
Conclusions: In this prospective study of 1,299 B1 and B2 mutation carriers, HRT following RRSO was not associated with an increased risk of breast cancer.
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*1007*
A randomized phase III study of iniparib (BSI-201) in combination with gemcitabine/carboplatin (G/C) in metastatic triple-negative breast cancer (TNBC).
J. O’Shaughnessy,
Conclusions: Although this study demonstrated a consistent safety profile to that of the phase II study, addition of I to GC did not meet the pre-specified criteria for significance for co-primary endpoints of OS and PFS in pts with mTNBC. Analyses aimed at further elucidating these findings are ongoing (clinicaltrials.gov: NCT00938652).
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7/ Chłoniaki
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*8000*
R-CHOP14 versus R-CHOP21: Result of a randomized phase III trial for the treatment of patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma.
D. Cunningham,8001
Conclusions: There is no evidence that R-CHOP14 improves patients OS or PFS comparing with the standard R-CHOP21.
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*8004 *
Maintenance with rituximab after autologous stem cell transplantation in relapsed patients with CD20 diffuse large B-cell lymphoma (DLBCL): CORAL final analysis
C. Gisselbrecht,
Conclusions: There was no difference between R-ICE and R-DHAP and between post ASCT maintenance with R or O. Women did significantly better after ASCT with rituximab. Early relapses to upfront rituximab-based chemotherapy have a poor prognosis.
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8/ Nowotwory ginekologiczne
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*Video dyskusja:*
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*LBA5002*
Randomized double-blind placebo-controlled international trial of abago-vomab maintenance therapy in patients with advanced ovarian cancer after complete response to first-line chemotherapy: The Monoclonal Antibody Immunotherapy for Malignancies of the Ovary by Subcutaneous Abago-vomab (MIMOSA) trial
J. Pfisterer
Conclusions:Treatment with A did not translate into a prolonged PFS.
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*LBA5007*
OCEANS: A randomized, double-blinded, placebo- controlled phase III trial of chemotherapy with or without bevacizumab (BEV) in patients with platinum-sensitive recurrent epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC).
C. Aghajanian,
Conclusions: Results show a statistically significant and clinically relevant benefit when bevacizumab is added to chemotherapy in patients with recurrent, platinum sensitive EOC, PPC, and FTC. This is the first phase III trial of an antiangiogenic to demonstrate a clinical benefit to these patients.
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9/ Leczenie wspomagające
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*LBA9014*
The ultra-low molecular weight heparin (ULMWH) semuloparin for prevention of venous thromboembolism (VTE) in patients with cancer receiving chemotherapy: SAVE ONCO study
G. Agnelli,
Conclusions:We have demonstrated the benefit of thromboprophylaxis with semuloparin in patients receiving chemotherapy without increase in major bleeding. Such patients should be considered for thromboprophylaxis.
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*9008*
Does circulating tumor necrosis factor (TNF) play a role in post-chemotherapy cerebral dysfunction in breast cancer survivors (BCS)?
P. A. Ganz,
Conclusions: Relationships between sTNFr2 and CC and brain metabolism in BCS are consistent with animal studies that show increased peripheral and brain TNF after CTx, and suggest CTx-induced TNF might represent a biological target for pharmacologic remediation of “chemobrain”.
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10/ Nowotwory układu moczowego
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*Video dyskusja:*
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*4503*
Axitinib versus sorafenib as second-line therapy for metastatic renal cell carcinoma (mRCC): Results of phase III AXIS trial.
B. I. Rini,
Conclusions:Axitinib demonstrated a significantly longer PFS and higher objective response rate vs. sorafenib with an acceptable safety profile as second-line therapy for mRCC.
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*4514*
A phase III randomized trial of intermittent versus continuous androgen suppression for PSA progression after radical therapy (NCIC CTG PR.7/SWOG JPR.7/ /CTSU JPR.7/ UK Intercontinental Trial CRUKE/01/013).
J.M.Crook
Conclusions: IAS is non-inferior to CAD with respect to OS.
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*4554*
Risk factor migration and survival: Analysis from international dataset of 3,748 metastatic renal cell carcinoma (mRCC) patients treated on clinical trials
S. Patil,
Conclusions: Pretreatment prognostic factors for shorter survival have decreased in proportion during more recent years. Higher representation of favorable risk factors may contribute to improvement in survival observed in recent years on clinical trials.
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*4559*
Polymorphisms as markers of sunitinib efficacy and toxicity in first-line treatment of renal clear cell carcinoma: Final results of a multicentric prospective study by the Spanish Oncology Genitourinary Group
J. Garcia-Donas,
Conclusions: To the best of our knowledge this is the first time a relevant role of VEGFR3 polymorphisms in response to first line treatment for renal clear cell carcinoma is found. If confirmed, inhibition of this target could have therapeutic implications.
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11/ Radioterapia
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*LBA1003*
NCIC-CTG MA.20: An intergroup trial of regional nodal irradiation in early breast cancer
T. J. Whelan,
Conclusions: The majority of women with node positive breast cancer are now managed by BCS followed by WBI and adjuvant systemic therapy. Results from MA.20 demonstrate that additional RNI reduces the risk of locoregional and distant recurrence, and improves DFS with a trend in improved OS.
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*1127*
Retrospective analysis of the effect on overall survival of radiotherapy and chemotherapy sequence as treatment for primary breast cancer
E. H. Gort,
Conclusions:The sequence of radio- and chemotherapy as treatment for primary breast cancer was not associated with overall-survival in a large retrospective cohort of patients after a median follow-up of approximately 5 years.
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*7051*
Outcomes of stereotactic body radiotherapy in patients with clinical stage I non-small cell lung cancer who are fit to undergo surgery.
S. Senan,
Conclusions: Despite a median age of 76 years, potentially operable pts who undergo primary SBRT have a median OS exceeding 5 years. This finding supports ongoing randomized clinical trials that compare surgery and SBRT in operable stage I NSCLC.
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12/ Miscellanea
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*2005*
Prognostic factors for chemotherapy-related toxicity in primary central nervous system lymphoma (PCNSL) treated with high-dose methotrexate (HDMTX) with or without ifosfamide: Results from a German phase III trial (G-PCNSL-SG-1)
P. Martus,
Conclusions:
This is the first report on prognostic factors for toxicity of HDMTX-based chemotherapy in PCNSL. The findings can be helpful when HDMTX-based chemotherapy in PCNSL patients is planned.
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*2006*
RTOG 0525: A randomized phase III trial comparing standard adjuvant temozolomide (TMZ) with a dose-dense (dd) schedule in newly diagnosed glioblastoma (GBM)
M. R. Gilbert,
Conclusions:This study did not demonstrate improved efficacy for dd TMZ for newly diagnosed GBM regardless of methylation status. However, it confirmed the prognostic significance of MGMT methylation in GBM. Additionally, it demonstrated the feasibility of tumor tissue collection, molecular stratification and collection of patient outcomes in a large transatlantic intergroup trial and established this as a viable clinical trial paradigm.
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NEWSLETTER PTO 