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https://media.blubrry.com/surgoncfiles/www.surgoncfiles.com/wp-content/uploads/2018/02/Pancreas-Adjuvant-Compiled.mp3

On this episode of the SO files, we interview Dr. Andrea Wang-Gillam MD/PhD, associate professor in the division of oncology at Wash U School of medicine and clinical director of the GI oncology, about systemic options for treating pancreatic adenocarcinoma. As much as we all love a good Whipple, this really is a systemic disease, and unlike other cancers 100% of patients regardless of stage will need some form of systemic treatment. Good thing we have great options to choose from! …Right?

Resources

NCCN guidelines

RCTs in the metastatic setting 

Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine

NEJM 2013

Daniel D. Von Hoff, M.D., Thomas Ervin, M.D., Francis P. Arena, M.D., E. Gabriela Chiorean, M.D., Jeffrey Infante, M.D., Malcolm Moore, M.D., Thomas Seay, M.D., Sergei A. Tjulandin, M.D., Wen Wee Ma, M.D., Mansoor N. Saleh, M.D., Marion Harris, M.D., Michele Reni, M.D., Scot Dowden, M.D., Daniel Laheru, M.D., Nathan Bahary, M.D., Ramesh K. Ramanathan, M.D., Josep Tabernero, M.D., Manuel Hidalgo, M.D., Ph.D., David Goldstein, M.D., Eric Van Cutsem, M.D., Xinyu Wei, Ph.D., Jose Iglesias, M.D., and Markus F. Renschler, M.D.

Take away: nab-Paclitaxel (Abraxane) added to gemcitabine improved survival when compared to gemcitabine alone (median OS 8.5 pos vs 6.7 mos, ORR 23% vs 7%). 

FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer

NEJM 2011

Thierry Conroy, M.D., Françoise Desseigne, M.D., Marc Ychou, M.D., Ph.D., Olivier Bouché, M.D., Ph.D., Rosine Guimbaud, M.D., Ph.D., Yves Bécouarn, M.D., Antoine Adenis, M.D., Ph.D., Jean-Luc Raoul, M.D., Ph.D., Sophie Gourgou-Bourgade, M.Sc., Christelle de la Fouchardière, M.D., Jaafar Bennouna, M.D., Ph.D., Jean-Baptiste Bachet, M.D., Faiza Khemissa-Akouz, M.D., Denis Péré-Vergé, M.D., Catherine Delbaldo, M.D., Eric Assenat, M.D., Ph.D., Bruno Chauffert, M.D., Ph.D., Pierre Michel, M.D., Ph.D., Christine Montoto-Grillot, M.Chem., and Michel Ducreux, M.D., Ph.D. for the Groupe Tumeurs Digestives of Unicancer and the PRODIGE Intergroup

FOLFIRINOX (oxaliplatin, irinotecan, leucovorin, fluorouracil) is a much more effective regimen than gemcitabine alone (median OS 11.1 mos vs 6.8 mos; ORR 32% vs 9%), but is a more toxic regimen with higher rate of adverse events. 

RCTS in the Adjuvant Setting 

Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial.

JAMA 2013.

Helmut Oettle, MD, PhD; Peter Neuhaus, MD, PhD; Andreas Hochhaus, MD, PhD; Jörg Thomas Hartmann, MD, PhD; Klaus Gellert, MD, PhD; Karsten Ridwelski, MD, PhD; Marco Niedergethmann, MD, PhD; Carl Zülke, MD, PhD; Jörg Fahlke, MD, PhD; Michael B. Arning, MD, PhD; Marianne Sinn, MD; Axel Hinke, PhD; Hanno Riess, MD, PhD

Take away: 6 months of gemcitabine treatment after complete resection was better for OS than no treatment (13.4 mos vs 6.7 mos). 

Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial.

Lancet 2017

Neoptolemos JP, Palmer DH, Ghaneh P, Psarelli EE, Valle JW, Halloran CM, Faluyi O, O’Reilly DA, Cunningham D, Wadsley J, Darby S, Meyer T, Gillmore R, Anthoney A, Lind P, Glimelius B, Falk S, Izbicki JR, Middleton GW, Cummins S, Ross PJ, Wasan H, McDonald A, Crosby T, Ma YT, Patel K, Sherriff D, Soomal R, Borg D, Sothi S, Hammel P, Hackert T, Jackson R, Büchler MW; European Study Group for Pancreatic Cancer.

Take away: Combination gemcitabine and capecitabine (Xeloda) did better than gemcitabine alone in patients with completely resected disease (OS 28 mos v 25.5 pos). 

New and exciting things coming down the pipeline… 1. Targeting desmoplastic reaction

HALO 202: Randomized Phase II Study of PEGPH20 Plus Nab-Paclitaxel/Gemcitabine Versus Nab-Paclitaxel/Gemcitabine in Patients With Untreated, Metastatic Pancreatic Ductal Adenocarcinoma.

JCO 2018

Hingorani SR, Zheng L, Bullock AJ, Seery TE, Harris WP, Sigal DS, Braiteh F, Ritch PS, Zalupski MM, Bahary N, Oberstein PE, Wang-Gillam A, Wu W, Chondros D, Jiang P, Khelifa S, Pu J, Aldrich C, Hendifar AE.

Take away: The addition of PEGPH20 (pegvorhyaluronidase alfa) to gem/abraxane improved PFS and OS compared to gem/abraxane alone in patients with untreated metastatic disease, especially in patients with hyaluron high tumors. Phase III study ongoing!!

2. Targeting cancer stem cells 

A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer

Ongoing phase Ib dose escalation study of BBI608 (Napabucasin), STAT3/cancer stem cell inhibitor, in combination with other standard chemotherapy regimens (gem/abraxane, FOLFIRINOX, FOLFIRI). Accrual slated to complete June 2018. 

3. Targeting innate immunity 

Targeting tumour-associated macrophages with CCR2 inhibition in combination with FOLFIRINOX in patients with borderline resectable and locally advanced pancreatic cancer: a single-centre, open-label, dose-finding, non-randomised, phase 1b trial.

Lancet Onc. 2016

Nywening TM, Wang-Gillam A, Sanford DE, Belt BA, Panni RZ, Cusworth BM, Toriola AT, Nieman RK, Worley LA, Yano M, Fowler KJ, Lockhart AC, Suresh R, Tan BR, Lim KH, Fields RC, Strasberg SM, Hawkins WG, DeNardo DG, Goedegebuure SP, Linehan DC.

Blockade of CCR2, as a means to suppress tumor infiltration of immunosuppressive tumor associated macrophages, in combination with FOLFIRINOX chemotherapy for borderline resectable or locally advanced PDAC resulted in a 49% objective tumor response rate.

Phase 1b Study of CCX872-B in Patients With Pancreatic Adenocarcinoma

CCR2 inhibition decreases tumor-associated macrophages and Treg cells, and increases CD8+ and CD4+ T cells in pancreatic tumors. In preliminary data presented at ASCO, CX872-B plus FOLFIRINOX resulted in a TCR of 78% and an ORR of 30 to 37% with no safety issues ascribed to CCX872-B use. Estimated study completion date December 2018. 

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https://media.blubrry.com/surgoncfiles/www.surgoncfiles.com/wp-content/uploads/2018/08/TailorX_Episode_original-edits.mp3

On this episode of SO Files, Alston, Brad and Linda take a closer look at the recently published TAILORx Clinical Trial Published in NEJM by Sparano and colleagues. The study expands the existing clinical application of the Oncotype DX score. If that score sounds familiar its because it has been quickly making its way into clinical practice over the past few years (see our last episode on the new AJCC guidelines!). We explain the origin of the score, how it has been incorporated into clinical practice thus far, and how this trial addresses a large gap in the existing literature.

Relevant Reading:

TAILORx Trial

Sparano et. al., NEJM 2018

A randomized controlled trial, designed to assess the utility of the Oncotype DX Score in predicting the need for chemotherapy, in addition to anti endocrine therapy, for hormone receptor +, Her2 -, node negative breast cancer. Bottom Line: Patients with an intermediate Oncotype DX Score of 11-25 can forgo chemotherapy, especially those patients >50 y/o.

NSABP B14 Study

Fisher et al. NEJM 1989

Overview of study layout in 1980’s – establishes adjuvant tamoxifen > no adjuvant therapy in ER+/Node negative patients.

NSABP B20 Study

Fisher et al. JNCI 1997

Overview of study layout in 1990’s – establishes chemo + endocrine for ER+/Node negative patients = decreased recurrence. 

Oncotype Dx Study

Paik et al. NEJM 2004

First description of OncotypeDx use and correlation with outcomes. Patients can now be stratified into low, intermediate, high risk of recurrence.

Oncotype DX applied study

Paik et al. J Clin Onc 2006

Same group shows that the score can be used to predict benefit from chemotherapy in individual patients.

ASCO 2007 Update

Harris et al. JCO 2007

ASCO first updates their guidelines to recommend use of gene assays in clinical care.

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https://media.blubrry.com/surgoncfiles/www.surgoncfiles.com/wp-content/uploads/2018/07/Breast-Staging-Compiled-1-1.mp3

On this episode of SO Files, Brad and Linda cover the updated staging guidelines for breast cancer that have been in practice (theoretically) since Jan 1, 2018. The possibilities for stage groups now cover a full six pages in the AJCC manual and you can hear Brad and Linda read through each one right here…. just kidding. We will however cover the major changes, the reasoning behind them, and talk about how they are fitting into practice with podcast favorite Dr. Cyr.

BONUS: listen to Brad, Alston and Linda survive a tornado during the live taping of this show!

Show Breakdown:

0-14 minutes: Background information with Brad, Linda and Alston

14 minutes- end: Brad and Linda interview Dr. Cyr

Relevant Reading:

NCCN Guidelines

Updated NCCN breast cancer guidelines, which includes the new AJCC 8th edition staging system.

AJCC 8th Edition Staging Chapter

Gabriel N. Hortobagyi, James L. Connolly, Carl J. D’Orsi, Stephen B. Edge, Elizabeth A. Mittendorf, Hope S. Rugo, Lawrence J. Solin, Donald L. Weaver, David J. Winchester, and Armando Giuliano

Detailed chapter outlining the new AJCC staging system. 

Oncotype DX Score Background

Background info on Oncotype DX Score from the company, Genomic Health, with links to relevant articles.

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https://media.blubrry.com/surgoncfiles/www.surgoncfiles.com/wp-content/uploads/2018/04/CRLM-BK-Compiled.mp3

Today we will be discussing the modern management of colorectal liver metastases. For today’s episode, we are excited to be welcoming on Dr. Yuman Fong, Sangiacomo Family Chair in Surgical Oncology and Surgical chair at City of Hope Cancer Center in California. Dr. Fong previously held the Murray F. Brennan Chair of Surgery at Memorial Sloan Kettering Cancer center, and is an international expert in both liver and pancreatic surgery.

Background Reading:

NCCN Guidelines: Colon Cancer

NCCN guidelines for colon cancer, which includes the management strategy for patients with liver metastases.

Sabiston Textbook of Surgery, Twentieth Edition

Overview of the surgical management of the liver and hepatic neoplasms, including metastatic colorectal cancer.

Articles Discussed:

Patient selection for the surgical treatment of resectable colorectal liver metastases.

Araujo RL, Riechelmann RP, Fong Y

2017 review article in The Journal of Surgical Oncology, outlining the surgical and medical management of colorectal liver metastases. Figure depicting the utilization of the colorectal liver metastasis clinical risk score in order to guide chemotherapy and surgical strategy.

Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: analysis of 1001 consecutive cases.

Fong Y, Fortner J, Sun RL, Brennan MF, Blumgart LH

Classic article depicting a clinical risk score that predicts survival in patients with resected colorectal liver metastasis. 5 preoperative factors, with each factor contributing to 1 point on the score, with more points = worse prognosis. At time of initial publication in 1998: 5 pts led to 14% 5 year survival vs. 60% for someone with 0 points. The 5 factors are: >1 liver metastasis, node positive primary, <12 months between primary colorectal tumor and liver met, >5cm liver tumor, preop CEA >200. 

Survival after hepatic resection for metastatic colorectal cancer: trends in outcomes for 1,600 patients during two decades at a single institution.

House MG, Ito H, Gönen M, Fong Y, Allen PJ, DeMatteo RP, Brennan MF, Blumgart LH, Jarnagin WR, D’Angelica MI

Data from Memorial Sloan Kettering that compared survival after resection for colorectal liver metastases for patients during 2 different eras: 1985-1998, and 1999-2004. Many of the patients in the more modern era were offered therapy with oxaliplatin or irinotecan, which likely led to the improved survival in these patients. Recurrence free survival in both generations were similar, suggesting that chemotherapy regimens and possibly patient selection differences led to differences in overall survival. 

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https://media.blubrry.com/surgoncfiles/www.surgoncfiles.com/wp-content/uploads/2017/11/ABSITE-Review-Cyr-Interview-LXJ-Edit-11-19.mp3

On this episode of the SO files, Brad and Linda welcome Assistant Professor of Surgery at Washington University in St. Louis/ Siteman Cancer Center, and co-author of the NCCN Clinical Practice Guidelines for Breast Cancer, Dr. Amy Cyr . We will take you through both benign, pre-malignant, and malignant breast oncology, with a focus on ABSITE relevant information.

Background Reading

NCCN Clinical Practice Guidelines in Breast Cancer, Revised Nov. 2017

A high-yield, recently updated review of the standard of care guidelines for non-invasive and invasive breast cancer. Includes updated AJCC 7th edition TNM staging tables.

Sabistons Textbook of Surgery, Chapter 34: Disease of the Breast

Kelly K Hunt and Elizabeth A Mittendorf.

Great review of breast pathology, with an overview of all facets of breast cancer–with tables and text highlighting key practice changing articles.

Papers/Resources we Mention in the Episode

NCCN Clinical Practice Guidelines in Breast Cancer, Revised Nov. 2017

A high-yield, recently updated review of the standard of care guidelines for non-invasive and invasive breast cancer. Includes updated AJCC 7th edition TNM staging tables.

Breast Cancer Screening for Women at Average Risk: 2015 Guideline Update From the American Cancer Society

Kevin C. Oeffinger, Elizabeth T. H. Fontham, Ruth Etzioni, Abbe Herzig, James S. Michaelson, Ya-Chen Tina Shih, Louise C. Walter, Timothy R. Church, Christopher R. Flowers, Samuel J. LaMonte, Andrew M. D. Wolf, Carol DeSantis, Joannie Lortet-Tieulent, Kimberly Andrews, Deana Manassaram-Baptiste, Debbie Saslow, Robert A. Smith, Otis W. Brawley, Richard Wender.

ACS updated recommendations for breast cancer screening for average risk women. Recommendations: Annual screening from 45-54, 55+ biennial screening or have the opportunity to continue annual screening. Screening should continue as long as the women has good overall health, and a life expectancy of 10+ years.

Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial.

Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M.

A practice changing article that established that for patients with clinical T1-2 N0 breast cancer with <3 SLN metastases found on SLN biopsy, there is no benefit of completion axillary lymph node dissection over no further surgical treatment of the axilla. This is high yield for the ABSITE, and a good thing to know for any medical student scrubbing in on a breast cancer operation during their surgical rotation.

Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial.

Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE, Cataliotti L, Westenberg AH, Klinkenbijl JH, Orzalesi L, Bouma WH, van der Mijle HC, Nieuwenhuijzen GA, Veltkamp SC, Slaets L, Duez NJ, de Graaf PW, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JW, Belkacemi Y, Petignat P, Schinagl DA, Coens C, Messina CG, Bogaerts J, Rutgers EJ.

AMAROS Phase III Trial: For patients with clinical T1-2 N0 breast cancer and 1 or more positive SLNs identified during surgery, axillary radiotherapy results in statistically equivalent axillary recurrence at 5 years vs. completion axillary lymph node dissection (1.19% and 0.43%, respectively, at 5 years). No significant differences in disease free or overall survival. Of note, at 5 years significantly more patients in the completion axillary lymph node dissection group had ipsilateral arm lymphedema than the axillary radiotherapy group (23% vs. 11%, respectively, p<0.0001).

Gail Model to Predict Breast Cancer Risk.

A commonly used model to predict future breast cancer risk for patients with no history of invasive breast cancer, DCIS or LCIS. Patients with a 5 year risk of >1.7% are candidates for chemoprevention.

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https://media.blubrry.com/surgoncfiles/www.surgoncfiles.com/wp-content/uploads/2017/12/Gastric-ABSITE-review-.mp3

Happy new years from SO Files! Ring in 2018 with an algorithm based review of gastric cancer management! We released this all out of order so excuse our Thanksgiving banter but the great news is that bad jokes never go out of style, so enjoy some useful review while adhering to your gym goals for at least the first week of January.

Resources

NCCN Guidelines – Gastric Cancer 

An updated, evidence based overview of gastric cancer management. Workup, and surgical/ medical treatment algorithms discussed.

7th Edition of the AJCC Cancer Staging Manual: Stomach

Updated AJCC staging information for gastric cancer.

Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial.

Songun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ.

15 year follow-up data from the Dutch D1D2 trial for gastric cancer. D2 lymphadenectomy resulted in a 29% overall survival for the D2 group vs. 21% for the D1 group (p=0.34). Gastric cancer related death was higher in the D1 group than the D2 group (48% vs. 37%, respectively, p=0.01).  In this trial a D2 gastrectomy included a splenectomy as standard protocol.

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