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Prolonged Versus Short-Duration Use of Nasogastric Tubes in Patients with Head and Neck Cancer During Radiotherapy Alone or

Combined Chemoradiotherapy

ESPELI, Vittoria, et al .

Abstract

To compare safety and effectiveness of prolonged (>28 days) versus short duration (≤28 days) use of nasogastric tube for enteral nutrition and weight loss prevention during curative radiotherapy with or without concurrent chemotherapy or cetuximab for head and neck cancer patients. We performed a retrospective study and database review of all patients at our center, treated with radiotherapy for head and neck cancer receiving enteral nutrition by nasogastric tube. Type of treatment, weight and body mass index changes, and related complications (gastroesophageal reflux, pneumonia, ulcer, feeding tube obstruction, or dislocation) were documented. Comparison between patients with prolonged (>28 days, group A) and short duration (≤28 days, group B) of EN through nasogastric tube was performed.

Data expressed as mean ± SD or median (min; max) values as appropriate, and analyzed by ANOVA repeated measures and Kaplan-Meier estimates. We identified 114 patients who fulfilled the inclusion criteria. Among them, 10% were treated with radiotherapy alone, while 90% received concurrent chemotherapy or cetuximab. Ninety-four [...]

ESPELI, Vittoria, et al . Prolonged Versus Short-Duration Use of Nasogastric Tubes in Patients with Head and Neck Cancer During Radiotherapy Alone or Combined Chemoradiotherapy.

Nutrition and Cancer , 2018, p. 1-6

PMID : 30273007

DOI : 10.1080/01635581.2018.1497670

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Prolonged Versus Short-Duration Use of

Nasogastric Tubes in Patients with Head and Neck Cancer During Radiotherapy Alone or Combined Chemoradiotherapy

Vittoria Espeli, Stephanie Vergotte, Pierre-Yves Dietrich, Claude Pichard &

Marco Siano

To cite this article: Vittoria Espeli, Stephanie Vergotte, Pierre-Yves Dietrich, Claude Pichard &

Marco Siano (2018): Prolonged Versus Short-Duration Use of Nasogastric Tubes in Patients with Head and Neck Cancer During Radiotherapy Alone or Combined Chemoradiotherapy, Nutrition and Cancer, DOI: 10.1080/01635581.2018.1497670

To link to this article: https://doi.org/10.1080/01635581.2018.1497670

Published online: 01 Oct 2018.

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Prolonged Versus Short-Duration Use of Nasogastric Tubes in Patients with Head and Neck Cancer During Radiotherapy Alone or Combined Chemoradiotherapy

Vittoria Espelia, Stephanie Vergotteb, Pierre-Yves Dietrichc, Claude Pichardb, and Marco Sianod

aDepartment of Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland;bDepartment of Nutrition, Geneva University Hospital, Geneva, Switzerland;cDepartment of Oncology, Geneva University Hospital, Geneva, Switzerland;dDepartment of Oncology and Haematology, Cantonal Hospital, St. Gallen, Switzerland

ABSTRACT

To compare safety and effectiveness of prolonged (>28 days) versus short duration (28 days) use of nasogastric tube for enteral nutrition and weight loss prevention during cura- tive radiotherapy with or without concurrent chemotherapy or cetuximab for head and neck cancer patients. We performed a retrospective study and database review of all patients at our center, treated with radiotherapy for head and neck cancer receiving enteral nutrition by nasogastric tube. Type of treatment, weight and body mass index changes, and related complications (gastroesophageal reflux, pneumonia, ulcer, feeding tube obstruction, or dislocation) were documented. Comparison between patients with prolonged (>28 days, group A) and short duration (28 days, group B) of EN through nasogastric tube was per- formed. Data expressed as mean ± SD or median (min; max) values as appropriate, and ana- lyzed by ANOVA repeated measures and Kaplan-Meier estimates. We identified 114 patients who fulfilled the inclusion criteria. Among them, 10% were treated with radiotherapy alone, while 90% received concurrent chemotherapy or cetuximab. Ninety-four patients (82%, group A) had a nasogastric tube in place for a period>28 days and 20 (18%, group B) for 28 days during treatment. Patients were mainly men (86 patients, 75%), with a median age of 61 years (range 4973) and advanced stage IV disease in most cases (87 patients, 76%) without differences between both groups (p ¼ 0.53, 0.47, and 0.30, respectively).

Treatment discontinuation did not occur within both groups. Fifty-six patients (49%) devel- oped complications, without a significant difference between both groups (P¼ 0.23). Body weight and BMI changes did not differ during EN (0.8 ± 4.5 and0.3 ± 1.6), the oncological treatment (5.3 ± 4.0 and1.8 ± 1.4), or 6 months after the end of treatment (0.6 ± 4.4 and 0.2 ± 1.5). Our findings suggest that prolonged enteral nutrition by nasogastric tube is safe and effective in preventing weight loss during curative radiotherapy or radio-chemotherapy for head and neck cancer.

ARTICLE HISTORY Received 11 December 2017 Accepted 28 June 2018

Introduction

In Switzerland, head and neck cancers (HNCs) affect approximately 1,100 patients each year (16/100,000/

year). The incidence of this type of cancer is particu- larly high in Geneva (1,010 new cases in 10 years) and is associated with high consumption of alcohol and tobacco (1,2).

HNCs are treated with a multimodality approach, including surgery, radiotherapy (RT), and chemother- apy (3). Patients treated with RT or radiochemother- apy are at considerable risk for malnutrition. In fact, patients with HNC have a predisposition to malnutri- tion due to excessive alcohol consumption; the local- ization of the tumor results in functional problems, in

addition to mucositis, resulting directly from radio- chemotherapy as the primary treatment modality.

Weight loss, as a measurable parameter of malnutri- tion, was shown to be detrimental in HNC patients, leading to treatment breaks and compromising treat- ment plans leading to altered outcomes. Early identifi- cation and treatment of poor nutritional status may prevent weight loss and improve treatment outcomes (4–9). Although the impact of malnutrition on the prognosis of HNC has not yet been established, weight loss is a clear indicator of poor prognosis (7).

Increasing dietary intake and starting enteral nutrition (EN) to prevent therapy-associated weight loss and RT interruptions is recommended by the European

CONTACTVittoria Espeli vittoria.espeli@eoc.ch Department of Oncology, Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Switzerland.

ß2018 Taylor & Francis Group, LLC NUTRITION AND CANCER

https://doi.org/10.1080/01635581.2018.1497670

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Society for Clinical Nutrition and Metabolism (recom- mendation grade A). Routine EN is not recommended during RT or radiochemotherapy; however, it is rec- ommended in cases of preexisting malnutrition at the beginning of treatment or if malnutrition develops during treatment (10). EN can be delivered either via a nasogastric tube (NGT) or via percutaneous endo- scopic gastrostomy (PEG). Both NGT and PEG are equally effective in maintaining body weight, and there is insufficient data to recommend one applica- tion method over the other (11–15). For HNC patients, NGT placement is often preferred due to a low complication rate, less invasiveness, and lower costs compared to PEG. In common practice, NGT is chosen when EN is expected to last less than 4 weeks, whereas PEG is used for longer time periods. The safety and effectiveness of NGT application over lon- ger time periods, in terms of complication rates and body weight changes along with treatment interrup- tions, has not yet been evaluated.

In this retrospective study, the safety and effectivity of prolonged (>28 days) versus short duration (28 days) use of NGT for EN was compared during cura- tive RT or radiochemotherapy in patients with HNC.

Patients and methods

Data collection and eligibility criteria

A computerized database at the Head and Neck Cancer Unit of the Geneva University Hospital takes a census of patients undergoing routine staging proce- dures consisting of physical examination, routine hematology and blood chemistry, pan-endoscopy and imaging (facial IRM, chest X-ray, CT, and/or PET-CT scan, depending on the stage of the disease).

We reviewed all cases of adult patients that received EN by NGT during RT with or without con- current chemotherapy or immunotherapy for locally advanced HNCs (squamous or other histology) treated during a 3-year period. Patients receiving palliative treatment, those initiating EN after the completion of the oncology treatment, those with more than one tumor diagnosis, or with unavailable data, were excluded. Tumor sites were classified as oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, and unknown origin. The tumor stage was defined accord- ing to the seventh UICC classification of malignant tumors. Patients were grouped according to the dur- ation of EN through a NGT as prolonged (>28 days, group A) and short duration (28 days, group B).

Radiotherapy

RT was performed with intensity-modulated radio- therapy with curative intent upfront in unresectable cancers or in an adjuvant setting when radically resected patients presented risk factors for local relapse (R1, lymph node extracapsular spread). The mean total dose prescribed to the planned target vol- ume was 66 Gy for postoperative RT and 72 Gy for exclusive RT.

Chemotherapy and immunotherapy

Standard concurrent chemotherapy consisted of 100 mg/m2 cisplatin given every 3 weeks. For naso- pharynx tumors, the concurrent chemotherapy was 75 mg/m2 cisplatin on day 1 and 1,000 mg/m2/day flu- orouracil on days 1–4 given every 3 weeks. Patients deemed unfit for standard chemotherapy received 40 mg/m2 cisplatin weekly or weekly carboplatin AUC 2, or weekly cetuximab with a loading dose of 400 mg/m2followed by 250 mg/m2weekly.

Nutritional program

Nutritional status was routinely assessed before, dur- ing and after the treatment until 6 months after treat- ment completion. Dietary counseling was provided by a dietician before and during treatment as part of the global routine care, supervised by a physician from the Nutrition Unit. EN was present in cases of invol- untary weight loss of 10% in 6 months, persistent dysphagia, weight loss during radiotherapy, weight loss despite energy- and protein-rich liquid regime or intake of oral nutritive supplements. A nasogastric feeding tube (8 Fr/CH, 120 cm length, internal diam- eter 2.1 mm) and a pump was used to deliver liquid feed (Novasource EnergyVR Nestle Switzerland or PromoteVR, Abbott, USA) at a constant rate 24 h/day to reach 35 kcal/kg of body weight as recom- mended (10).

Efficacy and safety assessment

Body weight changes were determined by recording weight and body mass index (BMI) at the following time points: the time of diagnosis, at the beginning of radiotherapy, and then after 3 weeks, 6 weeks, at the end, 1 month after, 3 months after, and 6 months after radiotherapy termination. Furthermore, the parameters were assessed at the time of placement and at removal of the NGT. Patients’ BMIs (kg/m2) were considered underweight if the BMI was less than

2 V. ESPELI ET AL.

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18.5 (<70 years old) or less than 21 (>70 years), nor- mal between 18.5/21 and 24.9, overweight between 25 and 29.9, and obese when more than 30.

The following complications of NGT were recorded: accidental removal of the tube due to coughing or vomiting; autoremoval by the patient;

tube blockage; aspiration for pneumonia; ulceration of the nasal mucosa and esophageal-gastric reflux due to the interference of the tube with the lower esophageal sphincter causing reflux of the stomach contents.

Statistical analysis

Quantitative variables are described as the mean ± SD or median (min; max) as appropriate. Normality was tested using QQ plot and the Shapiro-Wilk test.

Qualitative variables are presented as the frequency and percentage. Complications are described as a fre- quency and the proportional hazards by v2 testing, survival analysis using Kaplan-Meier estimates and curves, expressed as the median survival time. The evolution of the BMI and the weight during EN was analyzed using a paired Student’st-test. The evolution of the parameters during and after radiotherapy treat- ment was analyzed using ANOVA with repeated measures. We considered a lack of sphericity when e was less than 0.9. In the case of violation of this assumption, ANOVA results were corrected using the Greenhouse-Geisser method. Median survival was described as the frequency and the proportion fol- lowed by the v2 test and a survival analysis using Kaplan-Meier representation, and the percentile sur- vival time. Significance was set at 5%. The data were analyzed using STATAVR 12.0 software.

Results

Patients’ characteristics

There were 114 patients with HNC treated with radio- therapy alone or concurrent chemo- or immunoradio- therapy that received EN by NGT and were included in our analysis. Patients’ characteristics are summar- ized inTable 1. NGT was applied for 28 days in 20 patients and for >28 days in 94 patients. The median age was 61 years (range 49–73), and most patients were male (75%). The most common site of the tumors was the oropharynx (47%), followed by the oral cavity (20%), hypopharynx (16%), larynx (10%), nasopharynx (5%), and unknown primary sites (2%).

Patients mainly presented in the advanced stage IV of disease (76%). There were no significant differences between the two groups.

Treatment characteristics and response

Treatment characteristics are described in Table 2. All patients were treated with curative radiotherapy either exclusive (75 patients, 66%) or in an adjuvant setting (39 patients, 34%). Most patients (90%) received concur- rent chemo- or immunoradiotherapy; weekly cisplatin (43 patients, 38%), 3-weekly cisplatin (25%), cetuximab (13%), carboplatin (8%), and cisplatin-fluorouracil (6%).

No patient discontinued treatment. Eighty-five patients (75%) obtained complete tumor remission, 12% a partial remission of their tumors, and 14% showed progression.

There was no significant difference in treatment response between the two groups. Median overall sur- vival could not be determined because more than 50%

of patients were alive at the time of analysis.

Complications of the NGT

The complications due to the NGT are summarized in Table 3. Fifty-six patients (49%) developed complica- tions, including 12 of 20 (40%) patients in the 28-day group and 44 of 94 (53%) patients in the Table 1. Patients' characteristics.

Duration of nasogastric tube

All 28 days >28 days P

No. patients (%) 114 20 (18%) 94 (82%)

GenderMale 86 (75%) 6 (30%) 22 (23%) 0.534

Age (mean ± SD) 61 ± 12 60 ± 8 62 ± 12 0.477

Site

Oropharynx 54 (47%) 9 (45%) 45 (48%) 0.001

Oral cavity 23 (20%) 2 (10%) 21 (22%)

Hypopharynx 18 (16%) 3 (15%) 15 (16%)

Larynx 11 (10%) 0 (0%) 11 (12%)

Nasopharynx 6 (5%) 5 (25%) 1 (1%)

Unknown 2 (2%) 1 (5%) 1 (1%)

Stage

I 0 (0%) 0 (0%) 0 (0%) 0.309

II 7 (6%) 2 (10%) 5 (5%)

III 20 (18%) 5 (25%) 15 (16%)

IV 87 (76%) 13 (65%) 74 (79%)

Table 2. Treatment's characteristics and outcome.

Duration of nasogastric tube

All 28 days >28 days P

No. patients (%) 114 20 (18%) 94 (82%)

Radiotherapy alone 11 (10%) 0 (0%) 11 (12%) 0.208 Combined treatment 103 (90%) 20 (100%) 83 (88%)

Low-dose cisplatin 43 (38%) 9 (45%) 34 (36%) 0.459 High-dose cisplatin 29 (25%) 2 (10%) 27 (28%) 0.081

Cetuximab 15 (13%) 3 (15%) 12 (13%) 0.725

Carboplatin 9 (8%) 1 (5%) 8 (9%) 1.0

Cisplatin/FU 7 (6%) 5 (25%) 2 (2%) 0.002

Treatment response

Complete remission 85 (75%) 18 (90%) 67 (72%) 0.241 Partial response 14 (12%) 1 (5%) 13 (14%) Progression disease 14 (14%) 1 (5%) 13 (14%)

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>28-day group (v2¼1.15, P¼0.284). The complica- tions were feeding tube ablation (40 patients, 71%), blockage (7 patients, 12%), pneumonia (6 patients 11%), ulceration (2 patients, 4%), and gastroesopha- geal reflux (1 patient, 2%). When analyzed by dur- ation of NGT, for the 28-day group and for the

>28-day group, feeding tube ablation was 83 versus 68%, blockage 0 versus 16%, pneumonia 8 versus 11%, nose ulceration 0 versus 5% and gastroesopha- geal reflux 8 versus 0%, respectively. Differences in the type of complications were not statistically signifi- cant (P¼0.23).

Nutritional outcome

The nutritional outcomes are described in Table 4.

The median duration of feeding tube presence was 58.5 days (range, 1–837 days) for all patients; 15 days for the 28-day group (range, 1–26 days) and 73.5 days for the>28-day group (range, 29–837 days). The weight and BMI curves were similar between the two groups during EN, during treatment, and 6 months after treatment completion. The BMI decreased between diagnosis and treatment completion and

remained stable between the end and 6 months after treatment completion for both groups (Fig. 1).

Discussion

Weight loss is common among HNC and it may result in malnutrition, treatment interruption, morbid- ity, poorer outcome, and deterioration in quality of life (7,16). It is important to recognize patients at risk for weight loss or malnutrition because nutritional support has a role in cancer treatment, especially if the cancer is curable. Intuitively, it is warranted to support nutritional interventions; however, it is important to balance their risks and benefits by keep- ing in mind that it is not always easy to choose the appropriate nutritional support measure, the right time point for application, and route of administration.

The ESPEN guidelines suggest application of EN for longer time periods (>28 days) via PEG instead of NGT, even if body weight is maintained similarly, the complication rate is not different and without clear patients’ preference. Moreover, the guidelines propose to consider prophylactic tube feeding in high-risk sit- uations, with a low level of evidence (10). It means that PEG is not mandatory and our data show that EN via NGT is safe and effective in HNC patients during radiochemotherapy.

In terms of safety, we observed no significant dif- ference in complications arising between the short (28 days) and prolonged (>28 days) use of NGT.

Therefore, our data do not support the recommenda- tion by the ESPEN guidelines in favor of PEG in this clinical setting. In addition, there is no strong evi- dence supporting PEG for prolonged EN in this set- ting (12). In our study, the mean duration of the NGT was 108 days, with a subgroup of 6 patients in Table 3. Complications related to the use of nasogastric tube.

Length of nasogastric tube

P All 28 days >28 days

No. patients (%) 114 20 (18%) 94 (82%)

Yes 56 (49%) 12 (60%) 44 (47%) 0.28

Ablation 40 (71%) 10 (83%) 30 (68%) 0.226

Blockage 7 (12%) 0 (0%) 7 (16%)

Pneumonia 6 (11%) 1 (8%) 5 (11%)

Nose ulceration 2 (4%) 0 (0%) 2 (5%)

GE reflux 1 (2%) 1 (8%) 0 (0%)

Onset of complication, median, days (range)

27 (1154) 10 (118) 35.5 (1154) <0.001

Table 4. Follow-up of nutritional parameters.

Duration of nasogastric tube

All 28 days >28 days P

No. patients (%) 114 20 (18%) 94 (82%)

Weight

(kg, mean ± SD)

68 (15) 73 (12) 67 (15) BMI

(kg/m2, mean ± SD)

23.7 (4.4) 25.2 (2.9) 23.4 (4.6) Evolution of weight

(kg, mean ± SD)

During EN 0.8 ± 4.5 0.1 ± 4.3 0.9 ± 4.5 0.362 During treatment 5.3 ± 4.0 7.1 ± 2.5 4.9 ± 4.2 0.266 6 Months after

end of treatment

0.6 ± 4.4 0.4 ± 3.7 0.8 ± 4.4 0.747 Evolution of BMI

(kg/m2, mean ± SD)

During EN 0.3 ± 1.6 0.0 ± 1.5 0.3 ± 1.6 0.325 During treatment 1.8 ± 1.4 2.5 ± 0.9 1.7 ± 1.4 0.198 6 Months after

end of treatment

0.2 ± 1.5 0.2 ± 1.4 0.3 ± 1.5 0.758

Figure 1. Evolution of BMI at diagnosis of cancer, during, and after treatment.

4 V. ESPELI ET AL.

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which NGT remained in place for even more than 6 months, without enhanced complication rates. In add- ition, we did not observe major complications, such as those previously described for PEG, including hem- orrhage, gastric perforation, or death (17–21).

Our nutritionists guaranteed control assessments before, during, and after treatment. This may have contributed to our positive results regarding safety. It has already been observed that nutritional surveillance may prevent weight loss (4,8). Moreover, in a systemic review, it has been found that nutritional counseling has a positive role in terms of quality of life for HNC patients treated with radiotherapy (22). It is therefore likely that nutrition counseling has an important role in the management of NGT by improving compliance and preventing complications. Prolonged use of NGT is applicable if nutrition counseling is available for the patients. In terms of efficacy, it is difficult to assess the role of weight loss as a negative prognostic factor.

In cases in which treatment-related mucositis with a subsequent weight loss of around 10% result in treat- ment interruptions, we can only assume that the out- come will improve if nutritional support is able to prevent weight loss of greater than 10%. We observed a mean weight loss during treatment of 5.1 kg, which corresponds to a 7.5% decrease compared to the mean weight at diagnosis. We, therefore, support the results reported in the literature.

The question remains whether there are differences for EN by NGT compared to other nutrition devices (especially PEG) for longer time periods. In a recent review of prospective and retrospective studies, patients presented weight loss despite EN via PEG, with a mean weight loss of 8.5 kg (23). A critical weight loss during treatment of 8.9 kg was observed in 50% of patients treated with chemoradiotherapy, with a third of these patients experiencing a 10% weight loss (24). Our data is comparable to previously pub- lished results for PEG application in HNC patients and suggests that EN through prolonged NGT appli- cation sufficiently prevents weight loss during radio- chemotherapy, even over long periods. However, our study cannot provide definitive information due to its retrospective nature, which warrants prospective con- trolled clinical trials to confirm our results.

In addition to safety and efficacy, the use of NGT seems more cost-effective than PEG. In a recent review, the authors highlighted the costs of the PEG procedure, which requires the intervention of two medical specialists (anesthesiologist and gastroenter- ologist or head and neck surgeon), operation room, and nurse surveillance, as well as the cost of the

device itself (15). Insertion of an NGT can usually be performed easily at the bedside by trained nursing staff and the device is inexpensive.

Conclusion

Our data suggests that prolonged use of NGT for EN (>28 days) is safe and effective during curative radio- chemotherapy for HNC. Prospective studies are needed to confirm the superiority of NGT over PEG for applications lasting longer than 28 days.

Disclosure statement

No potential conflict of interest was reported by the authors.

Authors' contributions

Vittoria Espeli and Stephanie Vergotte wrote the manu- script. All authors read and approved the final version of the manuscript.

Funding

This study did not receive funding.

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