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Article: The Impact of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) versus Conventional Surgery on Patient-Reported Outcomes: A Comparative Cohort Study between the CAIRO6 Trial and the PROCORE Study.

Bakkers, Checca / van de Vlasakker, Vincent C J / Rovers, Koen P B / Lurvink, Robin J / Nienhuijs, Simon W / Burger, Jacobus W A / Creemers, Geert-Jan M / Bonhof, Cynthia S / Mols, Floortje / de Hingh, Ignace H J T

Cancers

2023 Volume 15, Issue 3

Abstract: Purpose-To compare patient-reported outcomes (PROs) of patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) for colorectal peritoneal metastases to PROs of colorectal cancer (CRC) patients undergoing ... ...

Abstract	Purpose-To compare patient-reported outcomes (PROs) of patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) for colorectal peritoneal metastases to PROs of colorectal cancer (CRC) patients undergoing conventional surgery. Methods-Data were extracted from the CAIRO6 trial (CRS-HIPEC group) and the PROCORE study (conventional surgery group). Nine predefined PROs (derived from the EORTC QLQ-C30 questionnaire) were compared at baseline, in the early postoperative period and one year postoperatively, with correction for treatment with systemic therapy using linear mixed modeling. Results-In total, 331 patients were included: 71 in the CRS-HIPEC group and 260 in the conventional surgery group. All predefined PROs (fatigue, diarrhea, C30 summary score, Global Health Status, physical, role, emotional, cognitive, and social functioning) did not differ significantly between the groups at all three timepoints, and differential effects over time for all PROs did not differ significantly between the groups. Significant worsening of fatigue, C30 summary score, physical and role functioning (both groups), and cognitive and social functioning (conventional surgery group only) was present in the early postoperative period. All scores returned to baseline at one year postoperatively, except for physical and cognitive functioning in the conventional surgery group. Emotional functioning improved postoperatively in both groups compared to baseline. Conclusion-Despite a more extensive procedure with greater risk of morbidity, CRS-HIPEC in patients with colorectal peritoneal metastases did not have a greater negative impact on PROs than conventional surgery in patients with CRC. Further, systemic therapy did not affect these PROs. These findings may facilitate future patient counseling and shared decision making in clinical practice.
Language	English
Publishing date	2023-01-27
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers15030788
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Article ; Online: Fecal levels of SCFA and BCFA during capecitabine in patients with metastatic or unresectable colorectal cancer.

Ziemons, Janine / Aarnoutse, Romy / Heuft, Anne / Hillege, Lars / Waelen, Janneke / de Vos-Geelen, Judith / Valkenburg-van Iersel, Liselot / van Hellemond, Irene E G / Creemers, Geert-Jan M / Baars, Arnold / Vestjens, Johanna H M J / Penders, John / Venema, Koen / Smidt, Marjolein L

Clinical and experimental medicine

2023 Volume 23, Issue 7, Page(s) 3919–3933

Abstract: Background: Gut bacteria-derived short-chain fatty acids (SCFA) and branched-chain fatty acids (BCFA) are considered to have beneficial metabolic, anti-inflammatory as well as anti-carcinogenic effects. Previous preclinical studies indicated ... ...

Abstract	Background: Gut bacteria-derived short-chain fatty acids (SCFA) and branched-chain fatty acids (BCFA) are considered to have beneficial metabolic, anti-inflammatory as well as anti-carcinogenic effects. Previous preclinical studies indicated bidirectional interactions between gut bacteria and the chemotherapeutic capecitabine or its metabolite 5-FU. This study investigated the effect of three cycles of capecitabine on fecal SCFA and BCFA levels and their associations with tumor response, nutritional status, physical performance, chemotherapy-induced toxicity, systemic inflammation and bacterial abundances in patients with colorectal cancer (CRC). Methods: Forty-four patients with metastatic or unresectable CRC, scheduled for treatment with capecitabine (± bevacizumab), were prospectively enrolled. Patients collected a fecal sample and completed a questionnaire before (T1), during (T2) and after (T3) three cycles of capecitabine. Tumor response (CT/MRI scans), nutritional status (MUST score), physical performance (Karnofsky Performance Score) and chemotherapy-induced toxicity (CTCAE) were recorded. Additional data on clinical characteristics, treatment regimen, medical history and blood inflammatory parameters were collected. Fecal SCFA and BCFA concentrations were determined by gas chromatography-mass spectrometry (GC-MS). Gut microbiota composition was assessed using 16S rRNA amplicon sequencing. Results: Fecal levels of the SCFA valerate and caproate decreased significantly during three cycles of capecitabine. Furthermore, baseline levels of the BCFA iso-butyrate were associated with tumor response. Nutritional status, physical performance and chemotherapy-induced toxicity were not significantly associated with SCFA or BCFA. Baseline SCFA correlated positively with blood neutrophil counts. At all time points, we identified associations between SCFA and BCFA and the relative abundance of bacterial taxa on family level. Conclusions: The present study provided first indications for a potential role of SCFA and BCFA during capecitabine treatment as well as implications for further research. Trial registration: The current study was registered in the Dutch Trial Register (NTR6957) on 17/01/2018 and can be consulted via the International Clinical Trial Registry Platform (ICTRP).
MeSH term(s)	Humans ; Capecitabine/adverse effects ; RNA, Ribosomal, 16S/genetics ; Fatty Acids, Volatile/chemistry ; Fatty Acids, Volatile/metabolism ; Fatty Acids, Volatile/pharmacology ; Fatty Acids/pharmacology ; Colorectal Neoplasms/drug therapy ; Bacteria/genetics ; Bacteria/metabolism ; Antineoplastic Agents/pharmacology
Chemical Substances	Capecitabine (6804DJ8Z9U) ; RNA, Ribosomal, 16S ; Fatty Acids, Volatile ; Fatty Acids ; Antineoplastic Agents
Language	English
Publishing date	2023-04-07
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2053018-3
ISSN	1591-9528 ; 1591-8890
ISSN (online)	1591-9528
ISSN	1591-8890
DOI	10.1007/s10238-023-01048-7
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Article: A Multidisciplinary Approach for the Personalised Non-Operative Management of Elderly and Frail Rectal Cancer Patients Unable to Undergo TME Surgery.

Ketelaers, Stijn H J / Jacobs, Anne / Verrijssen, An-Sofie E / Cnossen, Jeltsje S / van Hellemond, Irene E G / Creemers, Geert-Jan M / Schreuder, Ramon-Michel / Scholten, Harm J / Tolenaar, Jip L / Bloemen, Johanne G / Rutten, Harm J T / Burger, Jacobus W A

Cancers

2022 Volume 14, Issue 10

Abstract: Despite it being the optimal curative approach, elderly and frail rectal cancer patients may not be able to undergo a total mesorectal excision. Frequently, no treatment is offered at all and the natural course of the disease is allowed to unfold. These ... ...

Abstract	Despite it being the optimal curative approach, elderly and frail rectal cancer patients may not be able to undergo a total mesorectal excision. Frequently, no treatment is offered at all and the natural course of the disease is allowed to unfold. These patients are at risk for developing debilitating symptoms that impair quality of life and require palliative treatment. Recent advancements in non-operative treatment modalities have enhanced the toolbox of alternative treatment strategies in patients unable to undergo surgery. Therefore, a proposed strategy is to aim for the maximal non-operative treatment, in an effort to avoid the onset of debilitating symptoms, improve quality of life, and prolong survival. The complexity of treating elderly and frail patients requires a patient-centred approach to personalise treatment. The main challenge is to optimise the balance between local control of disease, patient preferences, and the burden of treatment. A comprehensive geriatric assessment is a crucial element within the multidisciplinary dialogue. Since limited knowledge is available on the optimal non-operative treatment strategy, these patients should be treated by dedicated multidisciplinary rectal cancer experts with special interest in the elderly and frail. The aim of this narrative review was to discuss a multidisciplinary patient-centred treatment approach and provide a practical suggestion of a successfully implemented clinical care pathway.
Language	English
Publishing date	2022-05-11
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers14102368
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Article ; Online: Phase I study of intraperitoneal irinotecan combined with palliative systemic chemotherapy in patients with colorectal peritoneal metastases.

van Eerden, Ruben A G / de Boer, Nadine L / van Kooten, Job P / Bakkers, Checca / Dietz, Michelle V / Creemers, Geert-Jan M / Buijs, Sanne M / Bax, Ramon / de Man, Femke M / Lurvink, Robin J / Diepeveen, Marjolein / Brandt-Kerkhof, Alexandra R M / van Meerten, Esther / Koolen, Stijn L W / de Hingh, Ignace H J T / Verhoef, Cornelis / Mathijssen, Ron H J / Burger, Jacobus W A

The British journal of surgery

2023 Volume 110, Issue 11, Page(s) 1502–1510

Abstract: Background: Patients with colorectal peritoneal metastases who are not eligible for cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) owing to extensive peritoneal disease have a poor prognosis. It was hypothesized that ... ...

Abstract	Background: Patients with colorectal peritoneal metastases who are not eligible for cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) owing to extensive peritoneal disease have a poor prognosis. It was hypothesized that these patients may benefit from the addition of intraperitoneal irinotecan to standard palliative systemic chemotherapy. Methods: This was a classical 3 + 3 phase I dose-escalation trial in patients with colorectal peritoneal metastases who were not eligible for CRS-HIPEC. Intraperitoneal irinotecan was administered every 2 weeks, concomitantly with systemic FOLFOX (5-fluorouracil, folinic acid, oxaliplatin)-bevacizumab. The primary objective was to determine the maximum tolerated dose and dose-limiting toxicities. Secondary objectives were to elucidate the systemic and intraperitoneal pharmacokinetics, safety profile, and efficacy. Results: Eighteen patients were treated. No dose-limiting toxicities were observed with 50 mg (4 patients) and 75 mg (9 patients) intraperitoneal irinotecan. Two dose-limiting toxicities occurred with 100 mg irinotecan among five patients. The maximum tolerated dose of intraperitoneal irinotecan was established to be 75 mg, and it was well tolerated. Intraperitoneal exposure to SN-38 (active metabolite of irinotecan) was high compared with systemic exposure (median intraperitoneal area under the curve (AUC) to systemic AUC ratio 4.6). Thirteen patients had a partial radiological response and five had stable disease. Four patients showed a complete response during post-treatment diagnostic laparoscopy. Five patients underwent salvage resection or CRS-HIPEC. Median overall survival was 23.9 months. Conclusion: Administration of 75 mg intraperitoneal irinotecan concomitantly with systemic FOLFOX-bevacizumab was safe and well tolerated. Intraperitoneal SN-38 exposure was high and prolonged. As oncological outcomes were promising, intraperitoneal administration of irinotecan may be a good alternative to other, more invasive and costly treatment options. A phase II study is currently accruing.
MeSH term(s)	Humans ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Bevacizumab/therapeutic use ; Colorectal Neoplasms/pathology ; Combined Modality Therapy ; Cytoreduction Surgical Procedures ; Hyperthermia, Induced ; Irinotecan ; Peritoneal Neoplasms/secondary ; Survival Rate
Chemical Substances	Bevacizumab (2S9ZZM9Q9V) ; Irinotecan (7673326042)
Language	English
Publishing date	2023-07-19
Publishing country	England
Document type	Clinical Trial, Phase I ; Journal Article
ZDB-ID	2985-3
ISSN	1365-2168 ; 0263-1202 ; 0007-1323 ; 1355-7688
ISSN (online)	1365-2168
ISSN	0263-1202 ; 0007-1323 ; 1355-7688
DOI	10.1093/bjs/znad228
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Article ; Online: Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases: protocol of the multicentre, open-label, phase II, INTERACT-II trial.

van de Vlasakker, Vincent C J / Guchelaar, Niels A D / van den Heuvel, Teun B M / Lurvink, Robin J / van Meerten, Esther / Bax, Ramon J F / Creemers, Geert-Jan M / van Hellemond, Irene E G / Brandt-Kerkhof, Alexandra R M / Madsen, Eva V E / Nederend, Joost / Koolen, Stijn L W / Nienhuijs, Simon W / Kranenburg, Onno / de Hingh, Ignace H J T / Verhoef, Cornelis / Mathijssen, Ron H J / Burger, Jacobus W A

BMJ open

2024 Volume 14, Issue 1, Page(s) e077667

Abstract: Introduction: The peritoneum is the second most affected organ for the dissemination of colorectal cancer (CRC). Patients with colorectal peritoneal metastases (CPM) face a poor prognosis, despite the majority of patients being treated with palliative ... ...

Abstract	Introduction: The peritoneum is the second most affected organ for the dissemination of colorectal cancer (CRC). Patients with colorectal peritoneal metastases (CPM) face a poor prognosis, despite the majority of patients being treated with palliative systemic therapy. The efficacy of palliative systemic therapy is limited due to the plasma-peritoneum barrier. The poor prognosis of unresectable CPM patients has resulted in the development of new treatment strategies where systemic therapy is combined with local, intraperitoneal chemotherapy. In the recently published phase I study, the maximum tolerated dose and thus the recommended phase II dose of intraperitoneal irinotecan was investigated and determined to be 75 mg. In the present study, the overall survival after treatment with 75 mg irinotecan with concomitant mFOLFOX4 and bevacizumab will be investigated. Materials and methods: In this single-arm phase II study in two Dutch tertiary referral centres, 85 patients are enrolled. Eligibility criteria are an adequate performance status and organ function, histologically confirmed microsatellite stable and unresectable CPM, no previous palliative therapy for CRC, no systemic therapy<6 months for CRC prior to enrolment and no previous cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS and HIPEC). Patients will undergo a diagnostic laparoscopy as standard work-up for CPM and if the peritoneal disease is considered unresectable (eg, Peritoneal Cancer Index (PCI)>20, too extensive small bowel involvement), a peritoneal access port and a port-a-cath are placed for administration of intraperitoneal and intravenous chemotherapy, respectively. Patients may undergo up to 12 cycles of study treatment. Each cycle consists of intravenous mFOLFOX4 with bevacizumab and concomitant intraperitoneal irinotecan (75 mg), which is repeated every 2 weeks, with a maximum of 12 cycles. Modified FOLFOX-4 regimen consists of 85 mg/m Ethics and dissemination: This study is approved by the Dutch Authority (CCMO, the Hague, the Netherlands), by a central medical ethics committee (MEC-U, Nieuwegein, the Netherlands) and by the institutional research boards of both research centres. Results will be submitted for publication in peer-reviewed medical journals and presented to patients and healthcare professionals. Trial registration number: NCT06003998.
MeSH term(s)	Humans ; Bevacizumab/therapeutic use ; Irinotecan/therapeutic use ; Peritoneum ; Peritoneal Neoplasms/secondary ; Colorectal Neoplasms/surgery ; Fluorouracil ; Leucovorin ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Clinical Trials, Phase II as Topic ; Multicenter Studies as Topic
Chemical Substances	Bevacizumab (2S9ZZM9Q9V) ; Irinotecan (7673326042) ; Fluorouracil (U3P01618RT) ; Leucovorin (Q573I9DVLP)
Language	English
Publishing date	2024-01-18
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2023-077667
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Article ; Online: Prognostic Implications of MRI-Detected EMVI and Tumor Deposits and Their Response to Neoadjuvant Therapy in cT3 and cT4 Rectal Cancer.

Schaap, Dennis P / Voogt, Eva L K / Burger, Jacobus W A / Cnossen, Jeltsje S / Creemers, Geert-Jan M / van Lijnschoten, Ineke / Nieuwenhuijzen, Grard A P / Rutten, Harm J T / Daniels-Gooszen, Alette W / Nederend, Joost / Kusters, Miranda

International journal of radiation oncology, biology, physics

2021 Volume 111, Issue 3, Page(s) 816–825

Abstract: Purpose: Magnetic resonance imaging-detected extramural venous invasion (mrEMVI) and tumor deposits (TDs) are risk factors for the development of local recurrence and distant metastases (DMs) in rectal cancer. However, little is known about their ... ...

Abstract	Purpose: Magnetic resonance imaging-detected extramural venous invasion (mrEMVI) and tumor deposits (TDs) are risk factors for the development of local recurrence and distant metastases (DMs) in rectal cancer. However, little is known about their response to neoadjuvant treatment and its relation to oncologic outcomes. This study evaluated the incidence and features of mrEMVI and TDs before and after neoadjuvant treatment in relation to the development of local recurrence and DMs. Methods and materials: Patients with cT3/4 rectal cancer without synchronous metastases who underwent surgery in a tertiary referral hospital were retrospectively analyzed. MRI scans were re-evaluated for the presence of mrEMVI, the occurrence of TDs, and response to neoadjuvant therapy (mr-vTRG). Results: In total, 277 patients were included, of whom 163 (58.8%) presented with mrEMVI. TDs were present in 56.4% of mrEMVI-positive and 9.6% of mrEMVI-negative patients (P < .001). The 5-year DM rate was significantly higher in mrEMVI-positive patients with and without TDs (45.2% and 35.9%, respectively) compared with mrEMVI-negative patients (25.7%; P = .012). After neoadjuvant treatment, the 5-year DM rate of patients with mr-vTRG 3-5 was 46.1%, whereas good responders (mr-vTRG 1-2) had a DM rate similar to mrEMVI-negative patients (25.7% and 25.7%, respectively; P = .002). The occurrence of TDs and larger mrEMVI size resulted in a lower likelihood of regression of mrEMVI. Conclusions: The prevalence of mrEMVI and TDs in cT3-4 rectal cancer is high and is associated with worsened oncologic outcomes. mrEMVI regression (mr-vTRG 1-2), which occured in 25% of the cases, leads to oncologic outcomes similar to those in patients without mrEMVI on baseline MRI.
MeSH term(s)	Extranodal Extension ; Humans ; Magnetic Resonance Imaging ; Neoadjuvant Therapy ; Neoplasm Invasiveness ; Prognosis ; Rectal Neoplasms/diagnostic imaging ; Rectal Neoplasms/therapy ; Retrospective Studies
Language	English
Publishing date	2021-06-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	197614-x
ISSN	1879-355X ; 0360-3016
ISSN (online)	1879-355X
ISSN	0360-3016
DOI	10.1016/j.ijrobp.2021.06.013
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Article ; Online: Patient-reported outcomes during repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy for isolated unresectable colorectal peritoneal metastases in a multicenter, single-arm, phase 2 trial (CRC-PIPAC).

Lurvink, Robin J / Rovers, Koen P / Wassenaar, Emma C E / Bakkers, Checca / Burger, Jacobus W A / Creemers, Geert-Jan M / Los, Maartje / Mols, Floortje / Wiezer, Marinus J / Nienhuijs, Simon W / Boerma, Djamila / de Hingh, Ignace H J T

Surgical endoscopy

2021 Volume 36, Issue 6, Page(s) 4486–4498

Abstract: Background: CRC-PIPAC prospectively assessed repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (PIPAC-OX) as a palliative monotherapy (i.e., without concomitant systemic therapy in between subsequent procedures) for ... ...

Abstract	Background: CRC-PIPAC prospectively assessed repetitive oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (PIPAC-OX) as a palliative monotherapy (i.e., without concomitant systemic therapy in between subsequent procedures) for unresectable colorectal peritoneal metastases (CPM). The present study explored patient-reported outcomes (PROs) during trial treatment. Methods: In this single-arm phase 2 trial in two tertiary centers, patients with isolated unresectable CPM received 6-weekly PIPAC-OX (92 mg/m Results: Twenty patients underwent 59 procedures (median 3 [range 1-6]). Several PROs solely worsened 1 week after the first procedure (index value - 0.10, p < 0.001; physical functioning - 20, p < 0.001; role functioning - 27, p < 0.001; social functioning - 18, p < 0.001; C30 summary score - 16, p < 0.001; appetite loss + 15, p = 0.007; diarrhea + 15, p = 0.002; urinary frequency + 13, p = 0.004; flatulence + 13, p = 0.001). These PROs returned to baseline at subsequent time points. Other PROs worsened 1 week after the first procedure (fatigue + 23, p < 0.001; pain + 29, p < 0.001; abdominal pain + 32, p < 0.001), second procedure (fatigue + 20, p < 0.001; pain + 21, p < 0.001; abdominal pain + 20, p = 0.002), and third procedure (pain + 22, p < 0.001; abdominal pain + 22, p = 0.002). Except for appetite loss, all changes were clinically relevant. All analyzed PROs returned to baseline 4 weeks after the third procedure. Conclusions: Patients receiving repetitive PIPAC-OX monotherapy for unresectable CPM had clinically relevant but reversible worsening of several PROs, mainly 1 week after the first procedure. Trial registration: Clinicaltrials.gov: NCT03246321; Netherlands trial register: NL6426.
MeSH term(s)	Abdominal Pain/drug therapy ; Aerosols/therapeutic use ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/pathology ; Fatigue ; Humans ; Oxaliplatin ; Patient Reported Outcome Measures ; Peritoneal Neoplasms/drug therapy ; Peritoneal Neoplasms/secondary
Chemical Substances	Aerosols ; Oxaliplatin (04ZR38536J)
Language	English
Publishing date	2021-11-10
Publishing country	Germany
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	639039-0
ISSN	1432-2218 ; 0930-2794
ISSN (online)	1432-2218
ISSN	0930-2794
DOI	10.1007/s00464-021-08802-6
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Article ; Online: The Role of Intestinal Microbiota in Metastatic Colorectal Cancer Patients Treated With Capecitabine.

Aarnoutse, Romy / Ziemons, Janine / de Vos-Geelen, Judith / Valkenburg-van Iersel, Liselot / Wildeboer, Aurelia C L / Vievermans, Anne / Creemers, Geert-Jan M / Baars, Arnold / Vestjens, Hanneke J H M J / Le, Giang N / Barnett, David J M / Rensen, Sander S / Penders, John / Smidt, Marjolein L

Clinical colorectal cancer

2021 Volume 21, Issue 2, Page(s) e87–e97

Abstract: Background: Previous pre-clinical research has indicated that the intestinal microbiota can potentiate anti-tumour efficacy of capecitabine and that capecitabine treatment impacts intestinal microbiota composition and diversity. Using a longitudinal ... ...

Abstract	Background: Previous pre-clinical research has indicated that the intestinal microbiota can potentiate anti-tumour efficacy of capecitabine and that capecitabine treatment impacts intestinal microbiota composition and diversity. Using a longitudinal design, this study explores the associations between the intestinal microbiota and treatment response in patients with metastatic colorectal cancer (mCRC) during capecitabine treatment. Patients and methods: Patients with mCRC treated with capecitabine were prospectively enrolled in a multicentre cohort study. Patients collected a faecal sample and completed a questionnaire before, during, and after three cycles of capecitabine. Several clinical characteristics, including tumour response, toxicity and antibiotic use were recorded. Intestinal microbiota were analysed by amplicon sequencing of the 16S rRNA V4 gene-region. Results: Thirty-three patients were included. After three cycles of capecitabine, six patients (18%) achieved a partial response, 25 (76%) showed stable disease, and one (3%) experienced progressive disease. Of the 90 faecal samples were collected. Microbial diversity (α-diversity), community structure (β-diversity), and bacterial abundance on phylum and genus level were not significantly different between responders and non-responders and were not significantly affected by three cycles of capecitabine. Conclusion: This is the first clinical study with longitudinal intestinal microbiota sampling in mCRC patients that explores the role of the intestinal microbiota during treatment with capecitabine. Intestinal microbiota composition and diversity before, during, and after three cycles of capecitabine were not associated with response in this study population. Capecitabine did not induce significant changes in the microbiota composition and diversity during the treatment period. Individual effects of antibiotics during capecitabine treatment were observed.
MeSH term(s)	Anti-Bacterial Agents ; Capecitabine/therapeutic use ; Cohort Studies ; Colorectal Neoplasms/drug therapy ; Gastrointestinal Microbiome ; Humans ; RNA, Ribosomal, 16S/genetics
Chemical Substances	Anti-Bacterial Agents ; RNA, Ribosomal, 16S ; Capecitabine (6804DJ8Z9U)
Language	English
Publishing date	2021-10-17
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2112638-0
ISSN	1938-0674 ; 1533-0028
ISSN (online)	1938-0674
ISSN	1533-0028
DOI	10.1016/j.clcc.2021.10.004
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Article ; Online: Pressurized Intraperitoneal Aerosol Chemotherapy (Oxaliplatin) for Unresectable Colorectal Peritoneal Metastases: A Multicenter, Single-Arm, Phase II Trial (CRC-PIPAC).

Rovers, Koen P / Wassenaar, Emma C E / Lurvink, Robin J / Creemers, Geert-Jan M / Burger, Jacobus W A / Los, Maartje / Huysentruyt, Clément J R / van Lijnschoten, Gesina / Nederend, Joost / Lahaye, Max J / Deenen, Maarten J / Wiezer, Marinus J / Nienhuijs, Simon W / Boerma, Djamila / de Hingh, Ignace H J T

Annals of surgical oncology

2021 Volume 28, Issue 9, Page(s) 5311–5326

Abstract: Background: Despite its increasing use, pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-OX) has never been prospectively investigated as a palliative monotherapy for colorectal peritoneal metastases in clinical trials. This ... ...

Abstract	Background: Despite its increasing use, pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-OX) has never been prospectively investigated as a palliative monotherapy for colorectal peritoneal metastases in clinical trials. This trial aimed to assess the safety (primary aim) and antitumor activity (key secondary aim) of PIPAC-OX monotherapy in patients with unresectable colorectal peritoneal metastases. Methods: In this two-center, single-arm, phase II trial, patients with isolated unresectable colorectal peritoneal metastases in any line of palliative treatment underwent 6-weekly PIPAC-OX (92 mg/m Results: Twenty enrolled patients underwent 59 (median 3, range 1-6) PIPAC-OX procedures. Major treatment-related adverse events occurred in 3 of 20 (15%) patients after 5 of 59 (8%) procedures (abdominal pain, intraperitoneal hemorrhage, iatrogenic pneumothorax, transient liver toxicity), including one possibly treatment-related death (sepsis of unknown origin). Minor treatment-related adverse events occurred in all patients after 57 of 59 (97%) procedures, the most common being abdominal pain (all patients after 88% of procedures) and nausea (65% of patients after 39% of procedures). Median hospital stay was 1 day (range 0-3). Response rates were 0% (radiological), 50% (biochemical), 56% (pathological), and 56% (ascites). Median progression-free and overall survival were 3.5 months (interquartile range [IQR] 2.5-5.7) and 8.0 months (IQR 6.3-12.6), respectively. Conclusions: In patients with unresectable colorectal peritoneal metastases undergoing PIPAC-OX monotherapy, some major adverse events occurred and minor adverse events were common. The clinical relevance of observed biochemical, pathological, and ascites responses remains to be determined, especially since radiological response was absent.
MeSH term(s)	Aerosols ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Colorectal Neoplasms/drug therapy ; Humans ; Oxaliplatin/therapeutic use ; Peritoneal Neoplasms/drug therapy
Chemical Substances	Aerosols ; Oxaliplatin (04ZR38536J)
Language	English
Publishing date	2021-02-05
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study
ZDB-ID	1200469-8
ISSN	1534-4681 ; 1068-9265
ISSN (online)	1534-4681
ISSN	1068-9265
DOI	10.1245/s10434-020-09558-4
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Article ; Online: Synchronous peritoneal metastases of small bowel adenocarcinoma: Insights into an underexposed clinical phenomenon.

Legué, Laura M / Simkens, Geert A / Creemers, Geert-Jan M / Lemmens, Valery E P P / de Hingh, Ignace H J T

European journal of cancer (Oxford, England : 1990)

2017 Volume 87, Page(s) 84–91

Abstract: Background: The aim of this population-based study was to provide insight into the incidence, risk factors and treatment-related survival of patients with peritoneal metastases (PM) of small bowel adenocarcinoma (SBA).: Methods: Data from the ... ...

Abstract	Background: The aim of this population-based study was to provide insight into the incidence, risk factors and treatment-related survival of patients with peritoneal metastases (PM) of small bowel adenocarcinoma (SBA). Methods: Data from the Netherlands Cancer Registry were used. All patients diagnosed with SBA between 2005 and 2014 were included. The influence of patient and tumour characteristics on the odds of developing PM was analysed. Subsequently, for all further analyses, patients without synchronous PM of SBA were excluded. The log-rank test and Kaplan-Meier analyses were conducted to estimate survival, and the Cox proportional hazards model was used to evaluate the risk of death. Results: Of the 1428 included patients diagnosed with SBA, 181 (13%) presented with synchronous PM. Synchronous PM was found in 9% of the duodenal tumours and in 17% of the more distal tumours. Median overall survival of all patients with PM was 5.9 months, whereas survival of both 11 months was observed in patients treated with primary tumour resection or palliative chemotherapy and 32 months after cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS+HIPEC). Poor prognostic factors for survival were age ≥70 years (hazard ratio [HR] 1.6, 95% confidence interval [CI] 1.1-2.2), systemic metastases other than PM (HR 2.0, 95% CI 1.4-2.9) and an advanced (HR 1.9, 95% CI 1.3-3.0) or unknown T-stage (HR 2.1, 95% CI 1.2-3.5). Conclusions: Synchronous PM was frequently encountered in SBA. Without treatment, prognosis was extremely poor. Survival was higher after primary tumour resection, palliative chemotherapy and CRS+HIPEC, but selection bias probably played a significant role calling for further clinical research.
Language	English
Publishing date	2017-11-10
Publishing country	England
Document type	Journal Article
ZDB-ID	82061-1
ISSN	1879-0852 ; 0277-5379 ; 0959-8049 ; 0964-1947
ISSN (online)	1879-0852
ISSN	0277-5379 ; 0959-8049 ; 0964-1947
DOI	10.1016/j.ejca.2017.10.012
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Zs.A 456: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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