The role of circulating tumor DNA (ctDNA), tumor markers (TMs), and patient-reported outcomes (PROs) in predicting treatment response in patients with metastatic gastrointestinal (GI) cancer.

833 Background: Changes in ctDNA and serum TMs (CEA and CA19-9) can serve as predictors of response to systemic therapy in GI cancer patients (pts). Similarly, PROs correlate with survival and treatment response. We present a preliminary analysis of ctDNA, TMs, and PROs in predicting treatment response. Methods: We are enrolling 200 pts in a prospective study with metastatic pancreatic (PDAC), colorectal (CRC), gastroesophageal (GE), and biliary cancers. We are collecting ctDNA, TMs (CEA for all tumor types; CA19-9 for PDAC, GE, biliary), and PROs (FACT-G for QOL [higher scores indicate better QOL]; ESAS-r and PRO-CTCAE for symptoms; and PHQ-4 [consists of GAD-2 and PHQ-2 for anxiety and depression]; higher ESAS-r, PRO-CTCAE, and PHQ-4 scores reflect greater symptom burden) at baseline and 4 weeks. ctDNA is benchmarked against somatic tissue alterations, and serially assessed by digital droplet PCR. We correlated median percent change from baseline to 4 weeks for ctDNA, TMs, and PROs with treatment response (clinical benefit [CB], progressive disease [PD]). Results: From April to August 2019, we have enrolled 38/45 (84.4%) eligible pts (median age = 64 years; 36.8% female). Among these 38 pts, tumor types are PDAC (36.8%), CRC (31.6%), GE (28.9%), and biliary (2.6%). 18/38 pts were evaluable for ctDNA. Change in ctDNA was -94.5% in pts with CB (n = 10) and -19.5% in pts with PD (n = 8; p = 0.025). No correlation was observed between CEA and treatment response (p = 0.367). Change in CA19-9 was -1.5% for pts with CB and +47% for pts with PD (p = 0.019). Changes in PRO-CTCAE (p = 0.345), GAD-2 (p = 0.697), and ESAS scores (p = 0.743) did not differ between pts with CB and PD. However, changes in PHQ-2 (CB 0% v. PD +22.5%; p < 0.001), PHQ-4 (CB -8.5% v. PD +5%; p = 0.015), and FACT-G (CB +30% v. PD +5%; p = 0.049) were significant. Conclusions: Preliminary analysis suggests that ctDNA and PROs demonstrate promising utility for early prediction of treatment response, with favorable performance relative to standard TMs. Further analyses of larger pt numbers in this ongoing study may clarify the use and integration of these measures to better predict pt outcomes.

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Quality of Life and Symptom Burden 1 Month After Concussion in Children and Adolescents

Clinical Pediatrics ◽

10.1177/0009922818806308 ◽

2018 ◽

Vol 58 (1) ◽

pp. 42-49 ◽

Cited By ~ 4

Author(s):

David R. Howell ◽

Julie C. Wilson ◽

Michael W. Kirkwood ◽

Joseph A. Grubenhoff

Keyword(s):

Quality Of Life ◽

Physical Health ◽

Children And Adolescents ◽

Symptom Burden ◽

Psychosocial Health ◽

Post Injury ◽

Persistent Symptoms ◽

Patient Reported ◽

A Prospective Study

We conducted a prospective study of children and adolescents (n = 176; mean age = 13.0 ±2.7 years; 38% female) assessed acutely post-concussion and again 30 days later. We investigated the association between symptom burden and quality of life (QOL) outcomes, as well as the effect of age on QOL. We assessed QOL using patient-reported Pediatric Quality of Life Inventory 4.0, and symptoms using the Health and Behavior Inventory (HBI). Acute (<2 days post-injury) HBI ratings demonstrated a low correlation ( R2 = 0.08) with physical health QOL and a moderate correlation with psychosocial health QOL ( R2 = 0.21) 30 days post-concussion. HBI ratings 30 days post-concussion demonstrated a moderately high correlation with physical health QOL ( R2 = 0.35) and psychosocial health QOL ( R2 = 0.57). Age was not significantly associated with physical or psychosocial QOL ratings. Impairments in QOL following concussion may identify children and adolescents who need additional referral to address persistent symptoms at this time.

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Changes in patient-reported outcomes (PROs) and tumor markers (TMs) to predict treatment response and survival in patients with metastatic gastrointestinal (GI) cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.154 ◽

2021 ◽

Vol 39 (28_suppl) ◽

pp. 154-154

Author(s):

Joy X. Jarnagin ◽

Islam Baiev ◽

Emily E. Van Seventer ◽

Yojan Shah ◽

Amirkasra Mojtahed ◽

...

Keyword(s):

Treatment Outcomes ◽

Treatment Response ◽

Clinical Benefit ◽

Progressive Disease ◽

Physical Symptoms ◽

Assessment System ◽

Survival Outcomes ◽

Gi Cancer ◽

Patient Reported ◽

Predict Treatment Response

154 Background: PROs assessing quality of life (QOL) and symptoms at a single timepoint frequently correlate with clinical outcomes in patients with cancer, yet efforts to understand how longitudinal changes in PROs can predict for treatment outcomes are lacking. In practice, oncologists often use changes in serum TMs (CEA and CA19-9) to monitor patients with GI cancer, and thus we sought to examine associations of 1-month changes in PROs and TMs with treatment response and survival outcomes among patients with advanced GI cancer. Methods: We prospectively enrolled patients with metastatic GI cancer prior to initiating chemotherapy at Massachusetts General Hospital from 5/2019-12/2020. At baseline (start of treatment) and 1-month later, we collected PROs (QOL [Functional Assessment of Cancer Therapy General {FACT-G}], physical symptoms [Edmonton Symptom Assessment System {ESAS}], and psychological symptoms [Patient Health Questionnaire-4 {PHQ-4}]) and TMs. We used regression models to examine associations of 1-month changes in PROs and TMs with treatment response (clinical benefit [defined as decreased or stable tumor burden] or progressive disease at the time of first scan) and survival outcomes (progression-free survival [PFS] and overall survival [OS]), adjusted for baseline values of each respective variable. Results: We enrolled 159 of 191 patients approached (83.2% enrollment); 134 had 1-month follow-up data (median age = 64 years [range: 28 to 84 years], 64.2% male, 46.3% pancreaticobiliary cancer). For treatment response, 63.4% had clinical benefit and 36.6% had progressive disease at the time of first scan (mean time to first scan = 2.01 months). Changes in PROs (ESAS-Total: OR = 0.97, p = 0.022; ESAS-Physical: OR = 0.96, p = 0.027; PHQ-4 depression: OR = 0.67, p = 0.014; FACT-G: OR = 1.07, p = 0.001), but not TMs (CEA: OR = 1.00, p = 0.836 and CA19-9: OR = 1.00, p = 0.796), were associated with clinical benefit at the time of first scan. Changes in ESAS-Total (HR = 1.03, p = 0.004), ESAS-Physical (HR = 1.03, p = 0.021), PHQ-4 depression (HR = 1.22, p = 0.042), FACT-G (HR = 0.97, p = 0.003), and CEA (HR = 1.00, p = 0.001) were predictors of PFS. Changes in ESAS-Total (HR = 1.03, p = 0.006) and ESAS-Physical (HR = 1.04, p = 0.015) were predictors of OS, but 1-month changes in TMs (CEA: HR = 1.00, p = 0.377 and CA19-9: HR = 1.00, p = 0.367) did not significantly predict for OS. Conclusions: We found that 1-month changes in PROs can predict for treatment response and survival outcomes in patients with advanced GI cancers. Notably, 1-month changes in CEA only correlated with PFS, while changes in CA19-9 did not significantly predict treatment response or survival outcomes. These findings highlight the potential for early changes in PROs to predict treatment outcomes while underscoring the need to monitor and address PROs in patients with advanced cancer. Clinical trial information: NCT04776837.

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Longitudinal and personalized detection of circulating tumor DNA (ctDNA) for monitoring efficacy of atezolizumab plus bevacizumab in patients with unresectable hepatocellular carcinoma (HCC).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.3531 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 3531-3531

Author(s):

Chih-Hung Hsu ◽

Shan Lu ◽

Alex Abbas ◽

Yinghui Guan ◽

Andrew X. Zhu ◽

...

Keyword(s):

Disease Progression ◽

Treatment Response ◽

Circulating Tumor Dna ◽

Tumor Burden ◽

Post Treatment ◽

Plasma Samples ◽

Whole Exome ◽

Previously Treated ◽

Phase 1B ◽

Tumor Types

3531 Background: ctDNA has emerged as a promising biomarker for noninvasive monitoring of treatment response and disease progression in many tumor types. However, the clinical use of ctDNA in patients with HCC has not been established. Here, we evaluated longitudinal and personalized detection of ctDNA for monitoring the treatment response to atezolizumab (atezo) + bevacizumab (bev) in patients with unresectable HCC not previously treated with systemic therapy. Methods: A subset (n = 48) of 104 patients with HCC who enrolled in Arm A of GO30140 (NCT02715531; Phase 1b) and received atezo + bev treatment were included in this study. These patients had 10 CR, 11 PR, 12 SD and 15 PD per IRF-assessed RECIST 1.1. Serial plasma samples were collected at baseline (Cycle [C]1 Day [D]1), during treatment (C2D1, C4D1) and at disease progression. Somatic mutations in individual tumors were identified via whole exome sequencing of archival tumor tissues or fresh biopsies collected before treatment. Personalized ctDNA assays (Signatera 16-plex multiplex PCR next-generation sequencing assay) specific to each patient’s tumor mutational signatures were successfully designed for 47 of 48 patients. Results: At C1D1, a median of 25.7 ng of cell-free DNA was extracted from 2-mL plasma samples. ctDNA was detected in 45 of 47 patients (96%), with a median of 70.6 mean tumor molecules/mL of plasma (MTM/mL) and a median of 1.8% mean variant allele frequency (mean VAF) in plasma. Higher ctDNA levels detected at C1D1 appeared to be associated with increased tumor burden ( P < 0.03). Dynamic changes in ctDNA levels post-treatment were associated with response at C4D1. ctDNA status changed from positive at baseline to negative in 7 of 10 CR (70%), 3 of 11 PR (27%), 1 of 11 SD (9%) and 0 of 11 PD (0%) patients. Longer PFS was observed in patients whose ctDNA became undetectable post-treatment. The median PFS in patients with ctDNA present vs cleared at C4D1 was 6.5 months and not reached, respectively (HR, 12 [1.7-93], log-rank P < 0.00029). Conclusions: Our study showed that Signatera, a personalized and tumor-informed ctDNA assay, could be used as a sensitive method for detecting ctDNA in patients with unresectable HCC. More importantly, our results illustrate the promise of ctDNA as an emerging biomarker that may potentially help to monitor treatment responses and disease progression in patients with HCC.

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Patient-reported outcomes (PROs) in older adults with gastrointestinal (GI) cancer undergoing surgery.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.29_suppl.159 ◽

2020 ◽

Vol 38 (29_suppl) ◽

pp. 159-159

Author(s):

Helen Perry Knight ◽

Zhi Ven Fong ◽

Carolyn L. Qian ◽

Emilia Kaslow-Zieve ◽

Chinenye C. Azoba ◽

...

Keyword(s):

Older Adults ◽

Postoperative Complications ◽

Physical Function ◽

Clinical Outcomes ◽

Surgical Outcomes ◽

Lower Risk ◽

Symptom Burden ◽

Depression Symptoms ◽

Gi Cancer ◽

Patient Reported

159 Background: Older adults with GI cancer often experience poor surgical outcomes, yet little is known about their PROs, such as physical function, quality of life (QOL), and physical and psychological symptom burden. Methods: As part of a randomized trial of perioperative geriatric care, we prospectively enrolled adults age ≥65 with GI cancer planning to undergo surgical resection. We asked patients preoperatively to self-report their physical function (activities of daily living [ADLs] and instrumental ADLs [IADLs]), QOL (EORTC QLQ-C30), symptom burden (Edmonton Symptom Assessment System [ESAS], scores > 3 considered moderate/severe [mod/sev]), depression symptoms (Geriatric Depression Scale [GDS], scores > 4 represent a positive screen for depression), and comorbidities. We used regression models to explore relationships among PROs and clinical outcomes (receiving planned surgery, postoperative complications [Clavien-Dindo], hospital readmissions within 90 days, and survival). Results: From 9/2016 - 4/2019, we enrolled 160 of 221 (72.4%) patients approached (median age: 72, range: 65-92). At baseline, most (53.1%) reported at least one comorbidity and required assistance with ADLs (94.8%) and IADLs (52.3%). Patients reported an average of 2.56 mod/sev ESAS symptoms, and 27.7% screened positive for depression. For surgical outcomes, 137 patients (85.6%) underwent planned surgery, and 99 (72.2%) of these had at least one postoperative complication. Greater independence with ADLs was associated with undergoing planned surgery (OR = 1.21, P = .02), lower risk of complications (OR = 0.81, P < .01), and improved survival (HR = 0.87, P = .02), but not readmissions. Greater independence with IADLs was associated with undergoing planned surgery (OR = 1.30, P = .03) and improved survival (HR = 0.73, P < .01), but not other outcomes. Higher baseline QOL was only associated with lower risk of postoperative complications (OR = 0.97, P = .04). Higher depression scores were only associated with worse survival (HR = 1.13, P = .02). Higher baseline symptom burden predicted for shorter time to readmission (HR = 1.13, p = .03). Patient-reported number of comorbidities was associated with shorter time to readmission (HR = 1.49, p = .03) and higher risk of complications (OR = 1.70, P = .03). Conclusions: Older adults with GI cancer often have baseline functional limitations and a high symptom burden, all of which are associated with worse clinical outcomes. Future work should study whether addressing preoperative PROs could improve older patients’ surgical outcomes. Clinical trial information: NCT02810652 .

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Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer

BMC Cancer ◽

10.1186/s12885-020-07440-w ◽

2020 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Markus Hecht ◽

Dennis Hahn ◽

Philipp Wolber ◽

Matthias G. Hautmann ◽

Dietmar Reichert ◽

...

Keyword(s):

Head And Neck ◽

Treatment Response ◽

Cox Regression ◽

Cell Cancer ◽

Symptom Burden ◽

Baseline Assessment ◽

Cox Regression Analysis ◽

Vas Score ◽

Platinum Based Chemotherapy ◽

Patient Reported

Abstract Background Head and neck squamous cell cancer (HNSCC) frequently causes severe symptoms that may be reduced, when the tumor is successfully treated. The SOCCER trial studied the association of treatment response with patient reported tumor symptom burden in first line treatment of recurrent and/or metastatic HNSCC. Methods In this prospective, multi-center, non-interventional trial patients were treated either with platinum-based chemotherapy and cetuximab or radiotherapy and cetuximab. Tumor symptom burden was assessed every four weeks with a questionnaire containing ten visual analogue scales (VAS, range 0–100), which were summarized to the overall VAS score. Results Fourhundred seventy patients were registered in 97 German centers. A total of 315 patients with at least the baseline and one subsequent questionnaire were available for analysis. Changes in the VAS score were rated as absolute differences from baseline. Negative values indicate improvement of symptoms. The overall VAS score improved significantly at the first post-baseline assessment in responders (− 2.13 vs. non-responders + 1.15, p = 0.048), and even more for the best post-baseline assessment (− 7.82 vs. non-responders − 1.97, p = 0.0005). The VAS for pain (− 16.37 vs. non-responders − 8.89, p = 0.001) and swallowing of solid food (− 16.67 vs. non-responders − 5.06, p = 0.002) improved significantly more in responders (best post-baseline assessment). In the multivariable Cox regression analysis, worse overall VAS scores were associated with worse overall survival (hazard ratio for death 1.12 per 10 points increment on the overall VAS scale, 95% CI 1.05–1.20, p = 0.0009). Conclusion In unselected patients beyond randomized controlled trials, treatment response lowers tumor symptom burden in recurrent and/or metastatic HNSCC. Trial registration ClinicalTrials.gov, NCT00122460. Registered 22 Juli 2005,

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Gastrointestinal malignancies and supportive care trials: a snapshot of the last two decades

BMJ Supportive & Palliative Care ◽

10.1136/bmjspcare-2020-002538 ◽

2020 ◽

pp. bmjspcare-2020-002538

Author(s):

Ramez Kouzy ◽

Joseph Abi Jaoude ◽

Bruce D Minsky ◽

Prajnan Das ◽

Albert C Koong ◽

...

Keyword(s):

Symptom Burden ◽

Progression Free Survival ◽

Secondary Endpoint ◽

Phase Iii ◽

Gastrointestinal Malignancies ◽

Gi Cancer ◽

Patient Reported ◽

Secondary Endpoints ◽

Gi Cancers ◽

Randomised Controlled

BackgroundPatients with gastrointestinal (GI) cancers experience a high symptom burden due to the effects of both cancer and treatment. As such, trials assessing symptom burden and supportive interventions are crucial. Here, we characterise the landscape of phase III GI cancer clinical trials and explore study outcomes centred on the patient’s quality of life (QoL).MethodsWe searched ClinicalTrials.gov for phase III randomised controlled trials (RCTs) registered between 2000 and 2017 that are assessing a therapeutic intervention in adult patients with cancer and grouped trials by GI disease sites.ResultsOverall, we identified 76 phase III trials specific to GI cancers that enrolled a total of 53 725 patients. When analysing the primary outcomes measured, the vast majority of studies (n=71, 86%) measured disease-related endpoints such as progression-free survival or overall survival. All trials had a secondary endpoint that measured adverse events, but only 30 trials (39%) included QoL measures as secondary endpoints. Of the 30 trials that included QoL secondary endpoints, only 16 (53%) reported these results. Only five trials (7%) assessed interventions aimed at supportive measures impacting disease-related or treatment-related toxicity. None of the supportive trials included QoL as a primary endpoint and only two of these trials (40%) included QoL as a secondary endpoint.ConclusionsMost GI cancer trials failed to incorporate patient-centred outcomes or QoL measures when studying new interventions. These findings call for greater integration of patient-reported metrics, which may lead to better care and outcomes for patients with GI malignancies.

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Changes in patient-reported outcomes (PROs) and tumor markers (TMs) to predict treatment response and survival outcomes in patients with metastatic gastrointestinal (GI) cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.6560 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 6560-6560

Author(s):

Joy X. Jarnagin ◽

Aparna Raj Parikh ◽

Emily E. Van Seventer ◽

Yojan Shah ◽

Islam Baiev ◽

...

Keyword(s):

Treatment Outcomes ◽

Treatment Response ◽

Clinical Benefit ◽

Progressive Disease ◽

Physical Symptoms ◽

Assessment System ◽

Survival Outcomes ◽

Gi Cancer ◽

Patient Reported ◽

Predict Treatment Response

6560 Background: PROs assessing quality of life (QOL) and symptoms at a single timepoint frequently correlate with clinical outcomes in patients with cancer, yet efforts to understand how longitudinal changes in PROs can predict for treatment outcomes are lacking. In practice, oncologists often use changes in serum TMs (CEA and CA19-9) to monitor patients with GI cancer, and thus we sought to examine associations of 1-month changes in PROs and TMs with treatment response and survival outcomes among patients with advanced GI cancer. Methods: We prospectively enrolled patients with metastatic GI cancer prior to initiating chemotherapy at Massachusetts General Hospital from 5/2019-12/2020. At baseline (start of treatment) and 1-month later, we collected PROs (QOL [Functional Assessment of Cancer Therapy General {FACT-G}], physical symptoms [Edmonton Symptom Assessment System {ESAS}], and psychological symptoms [Patient Health Questionnaire-4 {PHQ-4}]) and TMs. We used regression models to examine associations of 1-month changes in PROs and TMs with treatment response (clinical benefit [defined as decreased or stable tumor burden] or progressive disease at the time of first scan) and survival outcomes (progression-free survival [PFS] and overall survival [OS]), adjusted for baseline values of each respective variable. Results: We enrolled 159 of 191 patients approached (83.2% enrollment); 134 had 1-month follow-up data (median age = 64 years [range: 28 to 84 years], 64.2% male, 46.3% pancreaticobiliary cancer). For treatment response, 63.4% had clinical benefit and 36.6% had progressive disease at the time of first scan (mean time to first scan = 2.01 months). Changes in PROs (ESAS-Total: OR = 0.97, p = 0.022; ESAS-Physical: OR = 0.96, p = 0.027; PHQ-4 depression: OR = 0.67, p = 0.014; FACT-G: OR = 1.07, p = 0.001), but not TMs (CEA: OR = 1.00, p = 0.836 and CA19-9: OR = 1.00, p = 0.796), were associated with clinical benefit at the time of first scan. Changes in ESAS-Total (HR = 1.03, p = 0.004), ESAS-Physical (HR = 1.03, p = 0.021), PHQ-4 depression (HR = 1.22, p = 0.042), FACT-G (HR = 0.97, p = 0.003), and CEA (HR = 1.00, p = 0.001) were predictors of PFS. Changes in ESAS-Total (HR = 1.03, p = 0.006) and ESAS-Physical (HR = 1.04, p = 0.015) were predictors of OS, but 1-month changes in TMs (CEA: HR = 1.00, p = 0.377 and CA19-9: HR = 1.00, p = 0.367) did not significantly predict for OS. Conclusions: We found that 1-month changes in PROs can predict for treatment response and survival outcomes in patients with advanced GI cancers. Notably, 1-month changes in CEA only correlated with PFS, while changes in CA19-9 did not significantly predict treatment response or survival outcomes. These findings highlight the potential for early changes in PROs to predict treatment outcomes while underscoring the need to monitor and address PROs in patients with advanced cancer.

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Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer

10.21203/rs.3.rs-32561/v2 ◽

2020 ◽

Author(s):

Markus Hecht ◽

Dennis Hahn ◽

Philipp Wolber ◽

Matthias G. Hautmann ◽

Dietmar Reichert ◽

...

Keyword(s):

Head And Neck ◽

Treatment Response ◽

Cox Regression ◽

Cell Cancer ◽

Symptom Burden ◽

Baseline Assessment ◽

Cox Regression Analysis ◽

Vas Score ◽

Platinum Based Chemotherapy ◽

Patient Reported

Abstract Background: Head and neck squamous cell cancer (HNSCC) frequently causes severe symptoms that may be reduced, when the tumor is successfully treated. The SOCCER trial studied the association of treatment response with patient reported tumor symptom burden in first line treatment of recurrent and/or metastatic HNSCC.Methods: In this prospective, multi-center, non-interventional trial patients were treated either with platinum-based chemotherapy and cetuximab or radiotherapy and cetuximab. Tumor symptom burden was assessed every four weeks with a questionnaire containing ten visual analogue scales (VAS, range 0-100), which were summarized to the overall VAS score. Results: 470 patients were registered in 97 German centers. A total of 315 patients with at least the baseline and one subsequent questionnaire were available for analysis. Changes in the VAS score were rated as absolute differences from baseline. Negative values indicate improvement of symptoms. The overall VAS score improved significantly at the first post-baseline assessment in responders (-2.13 vs. non-responders +1.15, p=0.048), and even more for the best post-baseline assessment (-7.82 vs. non-responders -1.97, p=0.0005). The VAS for pain (-16.37 vs. non-responders -8.89, p=0.001) and swallowing of solid food (-16.67 vs. non-responders -5.06, p=0.002) improved significantly more in responders (best post-baseline assessment). In the multivariable Cox regression analysis, worse overall VAS scores were associated with worse overall survival (hazard ratio for death 1.12 per 10 points increment on the overall VAS scale, 95% CI 1.05-1.20, p=0.0009)Conclusion: In unselected patients beyond randomized controlled trials, treatment response lowers tumor symptom burden in recurrent and/or metastatic HNSCC. Trial registration: ClinicalTrials.gov, NCT00122460. Registered 22 Juli 2005, https://clinicaltrials.gov/ct2/show/NCT00122460

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Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer

10.21203/rs.3.rs-32561/v3 ◽

2020 ◽

Author(s):

Markus Hecht ◽

Dennis Hahn ◽

Philipp Wolber ◽

Matthias G. Hautmann ◽

Dietmar Reichert ◽

...

Keyword(s):

Head And Neck ◽

Treatment Response ◽

Cox Regression ◽

Cell Cancer ◽

Symptom Burden ◽

Baseline Assessment ◽

Cox Regression Analysis ◽

Vas Score ◽

Platinum Based Chemotherapy ◽

Patient Reported

Abstract Background: Head and neck squamous cell cancer (HNSCC) frequently causes severe symptoms that may be reduced, when the tumor is successfully treated. The SOCCER trial studied the association of treatment response with patient reported tumor symptom burden in first line treatment of recurrent and/or metastatic HNSCC.Methods: In this prospective, multi-center, non-interventional trial patients were treated either with platinum-based chemotherapy and cetuximab or radiotherapy and cetuximab. Tumor symptom burden was assessed every four weeks with a questionnaire containing ten visual analogue scales (VAS, range 0-100), which were summarized to the overall VAS score.Results: 470 patients were registered in 97 German centers. A total of 315 patients with at least the baseline and one subsequent questionnaire were available for analysis. Changes in the VAS score were rated as absolute differences from baseline. Negative values indicate improvement of symptoms. The overall VAS score improved significantly at the first post-baseline assessment in responders (-2.13 vs. non-responders +1.15, p=0.048), and even more for the best post-baseline assessment (-7.82 vs. non-responders -1.97, p=0.0005). The VAS for pain (-16.37 vs. non-responders -8.89, p=0.001) and swallowing of solid food (-16.67 vs. non-responders -5.06, p=0.002) improved significantly more in responders (best post-baseline assessment). In the multivariable Cox regression analysis, worse overall VAS scores were associated with worse overall survival (hazard ratio for death 1.12 per 10 points increment on the overall VAS scale, 95% CI 1.05-1.20, p=0.0009)Conclusion: In unselected patients beyond randomized controlled trials, treatment response lowers tumor symptom burden in recurrent and/or metastatic HNSCC.Trial registration: ClinicalTrials.gov, NCT00122460. Registered 22 Juli 2005, https://clinicaltrials.gov/ct2/show/NCT00122460

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Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer

10.21203/rs.3.rs-32561/v1 ◽

2020 ◽

Author(s):

Markus Hecht ◽

Dennis Hahn ◽

Philipp Wolber ◽

Matthias G. Hautmann ◽

Dietmar Reichert ◽

...

Keyword(s):

Head And Neck ◽

Treatment Response ◽

Cox Regression ◽

Cell Cancer ◽

Symptom Burden ◽

Baseline Assessment ◽

Cox Regression Analysis ◽

Vas Score ◽

Platinum Based Chemotherapy ◽

Patient Reported

Abstract Background Head and neck squamous cell cancer (HNSCC) frequently causes severe symptoms that may be reduced, when the tumor is successfully treated. The SOCCER trial studied the association of treatment response with patient reported tumor symptom burden in first line treatment of recurrent and/or metastatic HNSCC. Methods In this prospective, multi-center, non-interventional trial patients were treated either with platinum-based chemotherapy and cetuximab or radiotherapy and cetuximab. Tumor symptom burden was assessed every four weeks with a questionnaire containing ten visual analogue scales (VAS, range 0-100), which were summarized to the overall VAS score. Results 470 patients were registered in 97 German centers. A total of 315 patients with at least the baseline and one subsequent questionnaire were available for analysis. Changes in the VAS score were rated as absolute differences from baseline. Negative values indicate improvement of symptoms. The overall VAS score improved significantly at the first post-baseline assessment in responders (-2.13 vs. non-responders + 1.15, p = 0.048), and even more for the best post-baseline assessment (-7.82 vs. non-responders − 1.97, p = 0.0005). The VAS for pain (-16.37 vs. non-responders − 8.89, p = 0.001) and swallowing of solid food (-16.67 vs. non-responders − 5.06, p = 0.002) improved significantly more in responders (best post-baseline assessment). In the multivariable Cox regression analysis, worse overall VAS scores were associated with worse overall survival (hazard ratio for death 1.12 per 10 points increment on the overall VAS scale, 95% CI 1.05–1.20, p = 0.0009) Conclusion In unselected patients beyond randomized controlled trials, treatment response lowers tumor symptom burden in recurrent and/or metastatic HNSCC.

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