Publications by authors named "Ralf-Dieter Hofheinz"

Introduction: Precise prediction of pathological complete response (pCR) following neoadjuvant chemoradiotherapy (nCRT) in rectal cancer may identify candidates for non-operative management. The optimal selection of diagnostic tools is therefore of major clinical importance.

Methods: Clinical, laboratory, endoscopic and radiological data of patients with rectal cancer treated with nCRT and surgery at an academic medical center from 2010 to 2020 were retrospectively collected.

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This study aimed to investigate the effectiveness and safety of whole-body hyperthermia (WBH) in cancer patients, identifying predictive factors for successful treatment (reaching target temperature ≥ 38.5 °C) and assessing adverse effects. We conducted a retrospective analysis of 397 cancer patients receiving a total of 855 WBH treatment sessions at a single institution between January 2018 and December 2018.

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Introduction: Pharmacogenetics (PGx) plays a crucial role in precision medicine by identifying genetic variations that influence drug metabolism. For example, variants in dihydropyrimidine dehydrogenase (DPYD) have an impact on DPD enzyme activity and consequently on the metabolization of 5-fluorouracil, which can lead to severe adverse drug reactions. Therefore, pre-emptive DPYD genotyping was endorsed by the European Medicines Agency (EMA) in mid-2020 and subsequently included in national guidelines.

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Purpose: Many cancer patients rely on home parenteral nutrition (HPN), requiring intensive nursing care and facing higher infection risks. Multi-chamber bags (MCB) for individualized HPN could reduce manipulation, enhance patient autonomy, and lower infection risks. This study (IKF-t01/PEKANNUSS) compares MCB-based HPN to traditional 2/3-chamber bags in improving patient safety and independence.

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Introduction: Integrative therapeutic approaches are able to improve psychophysiological outcomes in cancer patients. Whether additional beneficial effects can be achieved by combining aromatherapy to sound intervention is unclear.

Methods: Eighty cancer patients were randomized (1:1) to either a 20-min sound intervention ("sound only," classical music via headphones) or a sound intervention combined with aromatherapy ("aroma").

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Purpose: In a multicenter phase 2 trial the sequence of chemoradiation therapy (CRT) followed by consolidation chemotherapy (CT) before total mesorectal excision demonstrated higher pathological complete response rates than induction CT before CRT. Here, we present findings on quality of life (QoL).

Methods And Materials: Patients with rectal carcinoma (cT3-4 cN0-2) were randomly assigned to group A (CT + CRT; N = 156) or group B (CRT + CT; N = 150).

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Background: Total neoadjuvant therapy has been shown to increase pathological complete response and disease-free survival in patients with locally advanced rectal cancer after total mesorectal excision (TME). We hypothesised that total neoadjuvant therapy could maximise the number of patients attaining a clinical complete response who could then be instead referred to organ preservation with watch and wait.

Methods: This open-label, multicentre, single-arm, phase 2 study (CAO/ARO/AIO-16) was conducted at four centres across Germany.

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Purpose: Rectal cancer disproportionately affects the elderly population, with more than half of cases diagnosed in individuals aged 70 years or older. Frail patients in this group often face significant challenges tolerating the standard treatment of total mesorectal excision (TME), due to elevated risks of surgical complications and perioperative morbidity. Advances in radiotherapy techniques offer a viable alternative, providing effective tumor control while minimizing treatment-related toxicity.

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Introduction: The introduction of immune checkpoint inhibitors (CPIs) in oncology has improved the long-term perspectives of many patients and is bringing the quality of life (QoL) into focus as a treatment-relevant variable. In clinical routine, standardized and reliable tools for collecting, understanding, and utilizing QoL information are needed. In the current work, an interdisciplinary consensus on aspects of QoL in standard clinical practice has been put forth.

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Low anterior resection (LAR) and abdominoperineal resection (APR) are the two main surgical procedures after preoperative chemoradiotherapy (CRT) for locally advanced rectal cancer. APR is associated with poorer prognosis; however existing data do not consider intensified CRT (5-Fluorouracil (5-FU)/Oxaliplatin + radiation) protocols. Clinicopathological data of patients treated with APR and LAR from the CAO/ARO/AIO-04 trial were analysed in terms of prognostic parameters and quality of life (QoL).

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Purpose: The FIRE-4 study randomly assigned patients with first-line wild-type (wt) metastatic colorectal cancer to either flourouracil (FU), folinic acid, and irinotecan (FOLFIRI) plus cetuximab until progression or intolerable toxicity (standard arm) or to FOLFIRI plus cetuximab followed by a switch maintenance treatment using FU plus bevacizumab (experimental arm). Here, we investigate the relevance of liquid biopsy (LB) RAS and BRAF testing compared with tissue-based analyses.

Patients And Methods: LBs were taken at baseline and during treatment and were analyzed for and mutations using the in vitro diagnostics-certified ONCOBEAM RAS procedure (Sysmex Inostics) and digital-droplet polymerase chain reaction technology.

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Background: This study investigated whether a sound intervention tuned to 432 Hz (Hz) yields differential effects on cardiovascular parameters and psychological outcomes compared to 443 Hz, which is the concert pitch in German professional orchestras.

Methods: Using a randomized cross-over design, patients with cancer were recruited to receive both a 15-minute sound intervention with a body monochord tuned to 432-443 Hz. Before (pre) and after (post) intervention, cardiovascular parameters were measured using the VascAssist2.

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Recent advancements in cancer treatment have shown the potential of immune checkpoint blockade (ICB) plus L. therapy in improving survival rates for patients with advanced or metastatic non-small-cell lung cancer (NSCLC). The objective of this study was to investigate factors associated with improved survival in NSCLC patients treated with a combination of ICB and abnobaViscum.

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Background And Objectives: The watch-and-wait (WW) strategy in patients after complete clinical response (cCR) following chemoradiotherapy for locally advanced rectal cancer (LARC) offers the option of organ preservation. The aim of this study was to assess the oncological outcomes of WW patients treated and followed up in a German referral cancer center.

Methods: In this retrospective study, we analyzed the clinical records of consecutive patients with LARC who underwent neoadjuvant radiotherapy/chemoradiotherapy at our institution between January 2020 and December 2023 and received non-operative management after cCR.

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Additional adjuvant treatment in patients with rectal cancer with limited response to neoadjuvant treatment to mitigate their higher risk of treatment failure remains controversial. This is a post hoc analysis of a cohort study of 3 randomized phase 2 or 3 trials (CAO/ARO/AIO-94, -04, and -12 trial) that included 1948 patients with locally advanced rectal adenocarcinoma. After excluding patients with missing information, 1788 patients (1254 men and 524 women; median age: 62.

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This article briefly summarizes clinically relevant new aspects of the recently published German, Austrian, and Swiss Onkopedia guideline for the treatment of locally advanced rectal cancer. Main aspects comprise (i) the use of total neoadjuvant therapy for rectal cancers with high-risk features, (ii) treatment with neoadjuvant chemotherapy for patients with a low risk for local recurrence, (iii) immunotherapy using dostarlimab in patients with MSI high/dMMR rectal cancer, as well as (iv) the implementation of organ sparing treatment concepts. The availability of several evidence-based treatment options requires intensive discussion within the multidisciplinary team as well as dedicated information for patients about treatment goals, options, and risks of individual treatment approaches.

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Importance: Patients with locally advanced rectal cancer and persistent lymph node metastases (PLNM) after neoadjuvant treatment are at high risk of developing locoregional and distant metastasis, yet optimal postsurgical treatment of these patients is limited.

Objective: To analyze the association of PLNM with pretreatment clinical parameters, intensity of neoadjuvant treatment, and long-term oncological outcomes.

Design, Setting, And Participants: This cohort study is a post-hoc analysis of 3 randomized clinical trials (Surgical Oncology Working Group of Germany [CAO], Radiological Oncology Working Group of Germany [ARO], and Working Group for Internal Oncology in the German Cancer Society [AIO]) conducted in Germany in 1994, 2004, and 2012 that included 1948 patients with locally advanced rectal cancer recruited between February 1995 and January 2018.

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Background: Total neoadjuvant therapy (TNT) has been used for patients with locally advanced rectal cancer. The optimal sequence of chemoradiotherapy (CRT) and chemotherapy (CT) is a matter of debate.

Methods: We performed a pooled analysis of the CAO/ARO/AIO-12 and OPRA multicenter, randomized phase 2 trials to identify patient subsets that could benefit from one TNT sequence over the other regarding disease-free survival (DFS).

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Introduction: The phase 2 RAMONA study demonstrated that second-line nivolumab ± ipilimumab immunotherapy was feasible and effective in older patients with advanced esophageal squamous cell cancer (ESCC). Here, we presented results from functional status (FS) and quality-of-life (QoL) analyses.

Materials And Methods: Patients aged ≥65 years with advanced ESCC and disease progression following first-line therapy were enrolled for study treatment with nivolumab ± ipilimumab.

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Importance: The prognosis of patients with adenocarcinoma of the esophagus and esophagogastric junction (AEG) is poor. From current evidence, it remains unclear to what extent preoperative chemoradiotherapy (CRT) or preoperative and/or perioperative chemotherapy achieve better outcomes than surgery alone.

Objective: To assess the association of preoperative CRT and preoperative and/or perioperative chemotherapy in patients with AEG with overall survival and other outcomes.

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Immunotherapy with PD-1/PD-L1 inhibitors has significantly improved the survival rates of patients with metastatic non-small-cell lung cancer (NSCLC). Results of a real-world data study investigating add-on VA ( L.) to chemotherapy have shown an association with the improved overall survival of patients with NSCLC.

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Background: Panel gene sequencing is an established diagnostic tool for precision oncology of solid tumors, but its utility for the treatment of cancers of the digestive system in clinical routine is less well documented.

Methods: We retrospectively identified patients with advanced or metastatic gastrointestinal, pancreaticobiliary or hepatic cancers who received panel gene sequencing at a tertiary university hospital from 2015 to 2022. For these cases, we determined the spectrum of genetic alterations, clinicopathological parameters and treatment courses.

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In the context of the COVID-19 pandemic, there has been a scarcity of resources with various effects on the care of cancer patients. This paper provides an English summary of a German guideline on prioritization and resource allocation for colorectal and pancreatic cancer in the context of the pandemic. Based on a selective literature review as well as empirical and ethical analyses, the research team of the CancerCOVID Consortium drafted recommendations for prioritizing diagnostic and treatment measures for both entities.

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