BOOK
Clinical Trials in Surgical Oncology, An Issue of Surgical Oncology Clinics of North America, E-Book
(2017)
Additional Information
Book Details
Abstract
This issue of Surgical Oncology Clinics of North America, guest edited by Dr. Elin R. Sigurdson, is devoted to Clinical Trials in Surgical Oncology. Dr. Sigurdson has assembled expert authors to review the following topics: Commentary on Randomized Controlled Trials; Randomized Clinical Trials in Soft Tissue Sarcoma; Randomized Clinical Trials in Gastrointestinal Stromal Tumors; Randomized Clinical Trials in Melanoma; Randomized Clinical Trials in Breast Cancer; Randomized Clinical Trials in Gastroesophageal Carcinoma; Randomized Clinical Trials in Hepatocellular Carcinoma; An Update on Randomized Clinical Trials in Advanced and Metastatic Colorectal Carcinoma; Randomized Clinical Trials in Colon and Rectal Cancer; Randomized Clinical Trials in Anal Cancers; The Elderly in Randomized Clinical Trials; Hereditary Syndromes in Clinical Trials; Future Clinical Trials: Genetically Driven Trials; Randomized Clinical Trials in Neuroendocrine Tumors, and more!
Table of Contents
| Section Title | Page | Action | Price |
|---|---|---|---|
| Front Cover | Cover | ||
| Clinical Trials in Surgical Oncology\r | i | ||
| Copyright\r | ii | ||
| Contributors | iii | ||
| CONSULTING EDITOR | iii | ||
| EDITOR | iii | ||
| AUTHORS | iii | ||
| Contents | vii | ||
| Foreword | vii | ||
| Preface | vii | ||
| Introduction: The Evolution of Oncology Clinical Research: Lessons Learned | vii | ||
| Randomized Controlled Trials in Soft Tissue Sarcoma: We Are Getting There! | vii | ||
| Randomized Clinical Trials in Gastrointestinal Stromal Tumors | vii | ||
| An Update on Randomized Clinical Trials in Melanoma | vii | ||
| An Update on Randomized Clinical Trials in Breast Cancer | viii | ||
| An Update on Randomized Clinical Trials in Gastric Cancer | viii | ||
| An Update on Randomized Clinical Trials in Hepatocellular Carcinoma | viii | ||
| An Update on Randomized Clinical Trials in Metastatic Colorectal Carcinoma | viii | ||
| Randomized Clinical Trials in Colon and Rectal Cancer | viii | ||
| Randomized Clinical Trials in Localized Anal Cancer | ix | ||
| Advancing Treatment Approach to the Older Patient with Cancer Through Clinical Trials Participation | ix | ||
| Randomized Controlled Trials in Hereditary Cancer Syndromes | ix | ||
| Randomized Controlled Trials in Neuroendocrine Tumors | x | ||
| Randomized Clinical Trials in Pancreatic Cancer | x | ||
| Future Clinical Trials: Genetically Driven Trials | x | ||
| SURGICAL ONCOLOGY\rCLINICS OF NORTH AMERICA\r | xi | ||
| FORTHCOMING ISSUES | xi | ||
| January 2018 | xi | ||
| April 2018 | xi | ||
| July 2018 | xi | ||
| RECENT ISSUES | xi | ||
| July 2017 | xi | ||
| April 2017 | xi | ||
| January 2017 | xi | ||
| Foreword | xiii | ||
| Preface | xv | ||
| The Evolution of Oncology Clinical Research: Lessons Learned | xvii | ||
| REFERENCES | xix | ||
| Randomized Controlled Trials in Soft Tissue Sarcoma: We Are Getting There! | 531 | ||
| Key points | 531 | ||
| INTRODUCTION | 532 | ||
| SURGERY | 532 | ||
| RADIATION | 532 | ||
| Extremity Soft Tissue Sarcoma | 532 | ||
| Sequencing of Radiotherapy and Surgery | 533 | ||
| Retroperitoneal Sarcoma | 534 | ||
| CHEMORADIATION | 534 | ||
| SYSTEMIC THERAPY | 535 | ||
| Adjuvant Chemotherapy | 535 | ||
| Neoadjuvant Chemotherapy | 535 | ||
| Regional Techniques | 536 | ||
| Intraperitoneal Chemotherapy | 536 | ||
| Advanced/Metastatic Disease | 537 | ||
| CHEMOSENSITIVE SOFT TISSUE SARCOMAS: RHABDOMYOSARCOMA AND EWING SARCOMA | 539 | ||
| Ewing's Sarcoma | 539 | ||
| Rhabdomyosarcoma | 539 | ||
| DISCUSSION | 540 | ||
| REFERENCES | 541 | ||
| Randomized Clinical Trials in Gastrointestinal Stromal Tumors | 545 | ||
| Key points | 545 | ||
| THE ROLE OF IMATINIB IN ADJUVANT THERAPY | 546 | ||
| THE ROLE OF IMATINIB IN UNRESECTABLE OR METASTATIC DISEASE | 548 | ||
| NOVEL TYROSINE KINASE INHIBITORS | 551 | ||
| FUTURE DIRECTIONS | 555 | ||
| REFERENCES | 556 | ||
| An Update on Randomized Clinical Trials in Melanoma | 559 | ||
| Key points | 559 | ||
| INTRODUCTION | 559 | ||
| PRIMARY MELANOMA | 559 | ||
| REGIONAL METASTATIC DISEASE | 560 | ||
| ADJUVANT TREATMENT OF HIGH-RISK MELANOMA | 561 | ||
| TREATMENT OF METASTATIC MELANOMA | 563 | ||
| LEVEL IA EVIDENCE IN MELANOMA | 564 | ||
| Surgical Trials | 564 | ||
| Hypothesis | 564 | ||
| Published abstract | 564 | ||
| Background | 564 | ||
| Methods | 564 | ||
| Results | 564 | ||
| Conclusions | 565 | ||
| Editor’s summary and comments | 565 | ||
| Hypothesis | 565 | ||
| Published abstract | 565 | ||
| Background | 565 | ||
| Methods | 565 | ||
| Results | 565 | ||
| Conclusions | 566 | ||
| Editor’s summary and comments | 566 | ||
| Hypothesis | 566 | ||
| Published abstract | 567 | ||
| Background | 567 | ||
| Methods | 567 | ||
| Results | 567 | ||
| Conclusions | 567 | ||
| Editor’s summary and comments | 567 | ||
| Hypothesis | 568 | ||
| Published abstract | 568 | ||
| Background | 568 | ||
| Methods | 568 | ||
| Findings | 568 | ||
| Interpretation | 569 | ||
| Editor’s note | 569 | ||
| Adjuvant Treatment | 569 | ||
| Hypothesis | 569 | ||
| Published abstract | 570 | ||
| Background | 570 | ||
| Patients and methods | 570 | ||
| Results | 570 | ||
| Conclusion | 570 | ||
| Editor’s summary and comments | 570 | ||
| Hypothesis | 570 | ||
| Published abstract | 571 | ||
| Background | 571 | ||
| Patients and methods | 571 | ||
| Results | 571 | ||
| Conclusion | 571 | ||
| Editor’s summary and comments | 571 | ||
| Hypothesis | 571 | ||
| Published abstract | 572 | ||
| Background | 572 | ||
| Patients and methods | 572 | ||
| Results | 572 | ||
| Conclusions | 572 | ||
| Editor’s summary and comments | 572 | ||
| Hypothesis | 573 | ||
| Published abstract | 573 | ||
| Purpose | 573 | ||
| Patients and methods | 573 | ||
| Results | 573 | ||
| Conclusion | 573 | ||
| Editor’s summary and comments | 573 | ||
| Hypothesis | 574 | ||
| Published abstract | 574 | ||
| Background | 574 | ||
| Methods | 574 | ||
| Results | 574 | ||
| Conclusions | 575 | ||
| Editor’s summary and comments | 575 | ||
| Hypothesis | 575 | ||
| Published abstract | 575 | ||
| Background | 575 | ||
| Patients and methods | 576 | ||
| Results | 576 | ||
| Conclusion | 576 | ||
| Editor’s summary and comments | 576 | ||
| Background | 576 | ||
| Methods | 576 | ||
| Results | 577 | ||
| Conclusions | 577 | ||
| Editors notes | 577 | ||
| Systemic Treatments (Metastatic Disease) | 577 | ||
| Hypothesis | 577 | ||
| Published abstract | 578 | ||
| Background | 578 | ||
| Patients and methods | 578 | ||
| Results | 578 | ||
| Conclusion | 578 | ||
| Editor’s summary and comments | 578 | ||
| Hypothesis | 578 | ||
| Published abstract | 579 | ||
| An Update on Randomized Clinical Trials in Breast Cancer | 587 | ||
| Key points | 587 | ||
| INTRODUCTION | 587 | ||
| LEVEL IA EVIDENCE: PROSPECTIVE RANDOMIZED SURGICAL TRIALS AND META-ANALYSES IN BREAST CANCER | 588 | ||
| Hypothesis | 588 | ||
| Published Abstract | 588 | ||
| Background | 588 | ||
| Methods | 588 | ||
| Findings | 588 | ||
| Interpretation | 588 | ||
| Editorial comments | 588 | ||
| LEVEL IA EVIDENCE: PROSPECTIVE RANDOMIZED TRIALS AND META-ANALYSES ON EVALUATION AND MANAGEMENT OF THE AXILLA IN BREAST CANCER | 589 | ||
| Hypothesis | 589 | ||
| Published Abstract | 589 | ||
| Background | 589 | ||
| Methods | 589 | ||
| Findings | 590 | ||
| Interpretation | 590 | ||
| Editorial comments | 590 | ||
| Hypothesis | 590 | ||
| Published Abstract | 590 | ||
| Background and objective | 590 | ||
| Methods | 590 | ||
| Results | 590 | ||
| Conclusions | 591 | ||
| Editorial comments | 591 | ||
| Hypothesis | 591 | ||
| Published Abstract | 591 | ||
| Background | 591 | ||
| Methods | 591 | ||
| Findings | 591 | ||
| Interpretation | 592 | ||
| Editorial comments | 592 | ||
| Hypothesis | 592 | ||
| Published Abstract | 592 | ||
| Background | 592 | ||
| Methods | 593 | ||
| Findings | 593 | ||
| Interpretation | 593 | ||
| Editorial comments | 593 | ||
| Hypothesis | 594 | ||
| Published Abstract | 594 | ||
| Importance | 594 | ||
| Objective | 594 | ||
| Design, setting, and patients | 594 | ||
| Main outcomes and measures | 594 | ||
| Results | 594 | ||
| Conclusions and relevance | 594 | ||
| Editorial comments | 595 | ||
| Hypothesis | 595 | ||
| Published Abstract | 595 | ||
| Background | 595 | ||
| Methods | 595 | ||
| Findings | 595 | ||
| Interpretation | 596 | ||
| Editorial comments | 596 | ||
| LEVEL IA EVIDENCE: PROSPECTIVE RANDOMIZED TRIALS AND META-ANALYSES ON RADIATION IN BREAST CANCER | 596 | ||
| Hypothesis | 596 | ||
| Published Abstract | 596 | ||
| Background | 596 | ||
| Methods | 596 | ||
| Results | 597 | ||
| Conclusions | 597 | ||
| Editorial comments | 597 | ||
| Hypothesis | 597 | ||
| Published Abstract | 597 | ||
| Purpose | 597 | ||
| Methods | 597 | ||
| Results | 598 | ||
| Conclusions | 598 | ||
| Editorial comments | 598 | ||
| Hypothesis | 598 | ||
| Published Abstract | 598 | ||
| Background | 598 | ||
| Methods | 598 | ||
| Findings | 598 | ||
| Interpretation | 599 | ||
| Editorial comments | 599 | ||
| Hypothesis | 599 | ||
| Published Abstract | 599 | ||
| Background | 599 | ||
| Methods | 600 | ||
| Findings | 600 | ||
| Interpretation | 600 | ||
| Editorial comments | 600 | ||
| Hypothesis | 600 | ||
| An Update on Randomized Clinical Trials in Gastric Cancer | 621 | ||
| Key points | 621 | ||
| SURGICAL MANAGEMENT | 621 | ||
| PERIOPERATIVE OUTCOMES | 622 | ||
| ADJUVANT THERAPY | 623 | ||
| Preoperative Chemotherapy | 623 | ||
| Preoperative Radiotherapy and Chemoradiotherapy | 624 | ||
| Postoperative Chemotherapy | 624 | ||
| Postoperative Radiotherapy and Chemoradiotherapy | 624 | ||
| Definitive Radiotherapy and Chemoradiotherapy Versus Surgery | 624 | ||
| Radiotherapy Versus Chemoradiotherapy | 625 | ||
| Surgery After Chemoradiotherapy | 625 | ||
| SUMMARY OF LEVEL IA EVIDENCE | 625 | ||
| Randomized, Controlled Trials in Esophageal Cancer | 625 | ||
| Clinical study 1 | 625 | ||
| Hypothesis | 626 | ||
| Published abstract | 626 | ||
| Background | 626 | ||
| Methods | 626 | ||
| Results | 626 | ||
| Conclusions | 626 | ||
| Editor's summary and comments | 626 | ||
| Clinical study 2 | 626 | ||
| Hypothesis | 627 | ||
| Published abstract | 627 | ||
| Background | 627 | ||
| Methods | 627 | ||
| Results | 627 | ||
| Conclusions | 627 | ||
| Editor's summary and comments | 627 | ||
| Clinical study 3 | 627 | ||
| Hypothesis | 628 | ||
| Published abstract | 628 | ||
| Background | 628 | ||
| Methods | 628 | ||
| Results | 628 | ||
| Conclusions | 628 | ||
| Editor's summary and comments | 628 | ||
| Clinical study 4 | 628 | ||
| An Update on Randomized Clinical Trials in Hepatocellular Carcinoma | 647 | ||
| Key points | 647 | ||
| INTRODUCTION | 647 | ||
| PREVENTION AND SCREENING | 648 | ||
| TREATMENT | 648 | ||
| Transplantation | 648 | ||
| Surgical Resection | 649 | ||
| Perioperative therapy | 650 | ||
| Local Ablation | 650 | ||
| Regional Therapy | 652 | ||
| Radiation Therapy | 653 | ||
| Systemic Therapy | 654 | ||
| First-line treatment | 654 | ||
| Second-line treatment | 659 | ||
| SUMMARY | 661 | ||
| REFERENCES | 661 | ||
| An Update on Randomized Clinical Trials in Metastatic Colorectal Carcinoma | 667 | ||
| Key points | 667 | ||
| INTRODUCTION | 667 | ||
| Equivalence of 5-Fluorouracil and Capecitabine | 668 | ||
| Irinotecan-Containing Regimens: 5-Flourouracil/LV with Irinotecan/Folinic Acid, Fluorouracil, Irinotecan/Capecitabine, Irin ... | 669 | ||
| Oxaliplatin-Containing Regimens: Folinic Acid, Fluorouracil, Oxaliplatin/Capecitabine, Oxaliplatin/XELOX | 670 | ||
| Folinic Acid, Fluorouracil, Oxaliplatin Versus Folinic Acid, Fluorouracil, Irinotecan | 671 | ||
| Oxaliplatin-Containing and Irinotecan-Containing Regimens: Oxaliplatin and Irinotecan/FOLFOXIRI | 672 | ||
| Oxaliplatin and irinotecan | 672 | ||
| FOLFOXIRI | 672 | ||
| Monoclonal Antibody Therapy | 673 | ||
| Bevacizumab | 673 | ||
| Other anti–vascular endothelial growth factor agents (aflibercept and ramucirumab) | 677 | ||
| Epidermal growth factor receptor inhibitors | 677 | ||
| Cetuximab | 677 | ||
| Bevacizumab versus cetuximab | 679 | ||
| Bevacizumab plus cetuximab | 679 | ||
| Panitumumab | 681 | ||
| Regorafenib | 681 | ||
| Trifluridine/Tipiracil | 681 | ||
| Immune Checkpoint Inhibitors | 682 | ||
| Resectable Liver Metastases | 682 | ||
| SUMMARY | 682 | ||
| REFERENCES | 683 | ||
| Randomized Clinical Trials in Colon and Rectal Cancer | 689 | ||
| Key points | 689 | ||
| COLON CANCER | 689 | ||
| Surgical Approach and Techniques | 689 | ||
| Endoscopic Stent for Colonic Obstruction | 690 | ||
| Primary Tumor Resection in Setting of Metastatic Disease | 690 | ||
| Perioperative Care/Enhanced Recovery After Surgery | 691 | ||
| Postoperative Surveillance Schedules | 691 | ||
| Adjuvant Therapy | 691 | ||
| RECTAL CANCER | 692 | ||
| Surgical Approach and Techniques | 692 | ||
| Reconstructive Techniques | 693 | ||
| Organ Preservation | 693 | ||
| Neoadjuvant Radiotherapy | 693 | ||
| Chemotherapy as a Radiation Sensitizer | 696 | ||
| Chemotherapy for Systemic Disease Control | 696 | ||
| REFERENCES | 700 | ||
| Randomized Clinical Trials in Localized Anal Cancer | 705 | ||
| Key points | 705 | ||
| INTRODUCTION | 705 | ||
| RADIATION VERSUS COMBINED MODALITY THERAPY | 706 | ||
| Anal Cancer Trial I | 706 | ||
| European Organization for the Research and Treatment of Cancer 22861 | 708 | ||
| ROLES OF MITOMYCIN-C, ADJUVANT CHEMOTHERAPY, AND RADIATION BOOST | 708 | ||
| Radiation Therapy Oncology Group 8704 | 708 | ||
| Radiation Therapy Oncology Group 9811 | 709 | ||
| Anal Cancer Trial II | 710 | ||
| Action Clinique Coordonnées en Cancérologie Digestive-03 | 711 | ||
| EFFECT OF A TREATMENT GAP | 712 | ||
| INTENSITY-MODULATED RADIOTHERAPY IN REDUCING THE ACUTE TOXICITY OF CHEMORADIATION | 712 | ||
| PROGNOSTIC FACTORS FROM RANDOMIZED TRIALS | 713 | ||
| ONGOING AND FUTURE RANDOMIZED CLINICAL TRIALS | 715 | ||
| SUMMARY | 716 | ||
| REFERENCES | 717 | ||
| Advancing Treatment Approach to the Older Patient with Cancer Through Clinical Trials Participation | 719 | ||
| Key points | 719 | ||
| CANCER IN OLDER ADULTS | 719 | ||
| PARTICIPATION OF OLDER PATIENTS WITH CANCER IN CLINICAL TRIALS | 722 | ||
| ELDERLY SPECIFIC CLINICAL TRIALS | 723 | ||
| ADVANCING KNOWLEDGE ABOUT ASSESSMENT AND SUPPORTIVE CARE OF THE OLDER PATIENT WITH CANCER | 724 | ||
| SUMMARY | 725 | ||
| REFERENCES | 725 | ||
| Randomized Controlled Trials in Hereditary Cancer Syndromes | 729 | ||
| Key points | 729 | ||
| INTRODUCTION | 729 | ||
| HEREDITARY BREAST AND OVARIAN CANCER: CLINICAL TRIALS IN SURGICAL ONCOLOGY | 731 | ||
| Screening Trials in Hereditary Breast and Ovarian Cancer | 731 | ||
| Chemoprevention Trials in Hereditary Breast and Ovarian Cancer | 733 | ||
| Surgical Trials in Hereditary Breast and Ovarian Cancer | 733 | ||
| Treatment Trials in Hereditary Breast and Ovarian Cancer | 736 | ||
| RANDOMIZED CONTROLLED TRIALS IN FAMILIAL ADENOMATOUS POLYPOSIS AND CARRIERS OF GERMLINE MUTATIONS IN ADENOMATOUS POLYPOSIS COLI | 736 | ||
| Chemoprevention of Adenomatous Polyps in Patients with Familial Adenomatous Polyposis | 737 | ||
| Chemoprevention of Colorectal Adenomas in Patients with Familial Adenomatous Polyposis | 737 | ||
| Chemoprevention of Upper Gastrointestinal Adenomas | 741 | ||
| Summary of Randomized Controlled Trials in Familial Adenomatous Polyposis | 742 | ||
| RANDOMIZED CONTROLLED TRIALS IN LYNCH SYNDROME/HEREDITARY NONPOLYPOSIS COLORECTAL CANCER | 742 | ||
| Randomized Clinical Trials Associated with Colorectal Cancer Screening in Lynch Syndrome | 743 | ||
| Randomized Clinical Trials of Chemoprevention in Lynch Syndrome | 743 | ||
| Randomized Biomarker Studies in Lynch Syndrome | 746 | ||
| Summary of Randomized Controlled Trials in Lynch Syndrome/Hereditary Nonpolyposis Colorectal Cancer | 746 | ||
| REFERENCES | 746 | ||
| Randomized Controlled Trials in Neuroendocrine Tumors | 751 | ||
| Key points | 751 | ||
| INTRODUCTION | 751 | ||
| CYTOTOXIC CHEMOTHERAPY | 752 | ||
| SOMATOSTATIN ANALOGUE THERAPIES | 756 | ||
| SMALL MOLECULE INHIBITORS OF MAMMALIAN TARGET OF RAPAMYCIN AND RECEPTOR TYROSINE KINASES | 760 | ||
| SUMMARY | 763 | ||
| REFERENCES | 764 | ||
| Randomized Clinical Trials in Pancreatic Cancer | 767 | ||
| Key points | 767 | ||
| REVIEW OF OLDER ADJUVANT TRIALS | 767 | ||
| Adjuvant Chemotherapy | 767 | ||
| Adjuvant Chemoradiation | 768 | ||
| RECENT ERA OF ADJUVANT THERAPY | 770 | ||
| Adjuvant Chemotherapy | 770 | ||
| Adjuvant Chemoradiation | 771 | ||
| Adjuvant Targeted Therapy | 772 | ||
| Adjuvant Immunotherapy | 772 | ||
| Ongoing Adjuvant Trials | 773 | ||
| NEOADJUVANT THERAPY IN BORDERLINE RESECTABLE DISEASE | 773 | ||
| NEOADJUVANT THERAPY IN RESECTABLE DISEASE | 775 | ||
| CHEMOTHERAPY IN LOCALLY ADVANCED OR METASTATIC DISEASE | 777 | ||
| Gemcitabine plus Albumin-bound Paclitaxel | 778 | ||
| Gemcitabine plus Erlotinib and Other Targeted Therapeutics | 778 | ||
| Gemcitabine plus Cisplatin | 780 | ||
| Gemcitabine plus Capecitabine | 780 | ||
| Gemcitabine and Other Fluoropyrimidine-based Therapies | 780 | ||
| FOLFIRINOX | 780 | ||
| Capecitabine and Continuous-infusion 5-Fluorouracil | 781 | ||
| Possible Role of Maintenance Therapy in Advanced Disease | 781 | ||
| Second-line Systemic Therapy in the Advanced Setting | 782 | ||
| CHEMORADIATION IN LOCALLY ADVANCED DISEASE | 783 | ||
| Chemoradiation Following Chemotherapy in Locally Advanced Disease | 784 | ||
| REFERENCES | 785 | ||
| Future Clinical Trials | 791 | ||
| Key points | 791 | ||
| INTRODUCTION | 791 | ||
| Targeting the Oncogenic Driver Mechanism | 792 | ||
| Signaling Redundancies, Tumor Clonality, and Escape Routes | 793 | ||
| Rethinking the Clinical Trials Conduct | 793 | ||
| SUMMARY | 795 | ||
| REFERENCES | 795 |