Prophylactic Gastrostomy Tubes in Patients Undergoing Intensive Irradiation for Cancer of the Head and Neck

Background  Most patients receiving accelerated fractionation radiotherapy or chemoradiotherapy for head and neck cancer experience severe mucositis. This can lead to decreased oral intake, resulting in dehydration, severe malnutrition, hospitalization, and/or interruption of radiotherapy.

Objective  To evaluate the effect of prophylactic gastrostomy tubes (PGTs) on the rates of weight loss, unplanned interruptions, and hospitalization during high-intensity head and neck radiotherapy.

Methods  A retrospective review was performed on 88 patients treated for locally advanced head and neck cancer with accelerated twice-a-day radiation (n = 59) or concurrent chemoradiotherapy (n = 29). Prophylactic gastrostomy tubes were placed in 36 (41%) of patients in anticipation of increased acute toxic effects from treatment. The remaining patients without PGTs served as a control group.

Results  Patients without PGTs lost an average 3.1 kg compared with 7.0 kg in the control group (P<.001). There were significantly fewer hospitalizations for nutritional or dehydration issues in those with PGTs than in the control group (13% vs 34%; P = .04, χ² test). Among those with good performance status, no patient with a PGT required a treatment interruption, compared with 18% of patients without a PGT (P = .08). Sixteen patients (31%) in the control group underwent therapeutic gastrostomy tube placement during or after radiation therapy.

Conclusions  The use of PGTs significantly reduces weight loss and the rate of hospitalization for dehydration and complications of mucositis. Treatment interruptions may also be avoided by the use of PGTs in patients with good performance status. We encourage patients scheduled for intensive radiation therapy to receive a PGT.

HEAD AND NECK cancers are commonly diagnosed in advanced stages and are not well controlled with standard radiotherapy.¹ In an attempt to improve local tumor control, radiation therapy has been delivered twice a day (accelerated or hyperfractionated)^2-4 or concurrently with chemotherapy.^5,6 Both of these types of treatment are characterized by increased toxic effects, leading to grade 3 or higher mucositis in the majority of patients as compared with 20% to 30% of patients treated with once-a-day radiotherapy alone.^7,8 This mucosal reaction combined with tumor-related anorexia, effects of previous surgery, radiation-related xerostomia, and loss of sense of taste can lead to significant weight loss during radiation treatment.^9,10 Severe dehydration and malnutrition may lead to unplanned treatment breaks or hospitalizations, thereby compromising treatment efficacy.^11,12

When oral intake is inadequate, percutaneous gastrostomy tubes (G-tubes) have been used successfully in patients with head and neck cancer.^13,14 In a surgical series, risk factors for prolonged enteral nutritional support were stage IV disease, pharyngeal primary tumor, the addition of radiation therapy, and preoperative weight loss.¹⁵ The role of G-tubes in patients undergoing definitive radiation therapy for head and neck cancer has been less well investigated.^16-18 Unselected patients undergoing G-tube placement before head and neck radiotherapy lose less weight during treatment and enjoy a better quality of life.^16,17

Patients treated with an altered fractionation radiotherapy regimen or with combined chemotherapy and radiation are particularly at risk for acute complications and nutritional deterioration. There are few data on the role of enteral nutritional support during high-intensity radiation therapy. We evaluated the effect of prophylactic gastrostomy tubes (PGTs) placed in anticipation of twice-a-day radiotherapy or chemoradiotherapy on weight loss, treatment interruptions, and unplanned hospital admissions.

A retrospective chart review was performed on patients undergoing an intensive course of definitive or postoperative radiation therapy for locally advanced squamous cell carcinoma of the head and neck. Between February 4, 1991, and August 13, 1997, 88 patients were treated at the Hospital of the University of Pennsylvania, Philadelphia, or the Philadelphia Veterans Affairs Medical Center with twice-a-day (BID) radiation (n = 59, 67%) or combined chemoradiation (n = 29, 33%). Cases treated with standard once-daily radiation without chemotherapy were excluded. The most common site of the primary lesion was the oropharynx (38 [43%]) followed by the larynx (17 [19%]). The majority (63 [72%]) of patients had stage IV disease according to the 1992 criteria of the American Joint Committee on Cancer (Table 1).

Thirty-six patients (41%) underwent PGT placement at the discretion of the treating physicians (M.M., G.S.W., R.S.W., A.A.C., and D.I.R.). In general, PGTs were recommended when increased acute toxic effects were anticipated secondary to treatment intensity. Nearly all G-tubes were placed via an endoscopic approach. The remaining 52 patients without PGTs in this series served as a control group. Because this was not a randomized protocol, patients with PGTs differed in pretreatment characteristics from those in the control group (Table 2). Patients with poorer performance status (P = .006) or oropharyngeal primary tumors (P<.001) were more likely to undergo PGT placement.

Median radiation dose was 72.4 Gy for patients treated on a BID basis and 70 Gy for patients treated with concurrent chemotherapy. The scheme developed at the Massachusetts General Hospital, Boston,⁴ was used in 33 (56%) of patients receiving BID radiation. Chemotherapy consisted of infusional paclitaxel in 10 patients and a cisplatin-based regimen in the remaining 19 patients. Patients' weights were measured at time of initial consultation, weekly during treatment, and at follow-up visits.

Outcome measures in this study included the frequency of unplanned breaks from radiation therapy, frequency of unplanned hospitalizations, weight loss during radiation therapy, and need for therapeutic gastrostomy tubes in patients without PGTs. Hospital admissions for dehydration, malnutrition, or therapeutic G-tube were considered nutrition related and analyzed as a separate end point. For patients undergoing BID radiation therapy by the technique developed at the Massachusetts General Hospital, which incorporated a planned 14-day break,⁴ an unplanned treatment break was an interruption longer than 14 days or an independent interruption. For all other patients, a treatment break was defined as an interruption of more than 3 days from radiation. Weight loss during radiotherapy was defined as a loss of at least 4.53 kg or 5% of pretreatment body weight. Patients who remained inpatients during the majority of treatment for social reasons (eg, transportation problems) were excluded from analysis on hospitalizations. All 5 of these patients exhibited poor performance status and underwent elective PGT placement before treatment.

Several patient-, tumor-, and treatment-related factors were assessed for each case. Patients were assigned a performance status score of favorable or unfavorable, where favorable included those with a Karnofsky score of 80 or more or an Eastern Cooperative Oncology Group performance score of 1 or less. The presence of pretreatment weight loss was defined as a documented loss of at least 4.53 kg or 5% of baseline body weight within the 6 months before radiotherapy. Tumor-related factors included site of primary disease, 1992 American Joint Committee on Cancer stage (IV vs II-III), and nodal stage (N2-3 vs N0-1). Treatment-related factors included the scheme of radiation therapy (chemoradiation vs BID radiation therapy) and dose of radiation (≥72 Gy vs <72 Gy). Risk factors for adverse complications were identified with logistic regression. Differences in proportions were assessed with a χ² test. Changes in patients' weights before and after radiotherapy were evaluated with paired t tests. Weights were compared between patient subsets with the Mann-Whitney U statistic. Significance was defined as P = .05 (2 tailed). Overall patient survival was determined with the Kaplan-Meier method.

Pretreatment weight loss was documented historically in 45 (51%) of patients, with an average weight loss of 9% of baseline body weight. During radiation therapy, approximately 66% of patients experienced weight loss greater than or equal to 4.53 kg or 5% of baseline weight. Mean pretreatment weight and nadir weight were 72.9 ± 17.7 kg and 67.0 ± 15.9 kg, respectively (P<.001). Mean weight loss for all patients was 5.3 ± 4.3 kg or 7.2% of pretreatment body weight (Figure 1). Weight loss was more than twice as great in the control group than in those with PGTs (7.0 ± 4.6 kg vs 3.1 ± 2.5 kg; P<.001). A loss of 5% or more of pretreatment body weight was seen in 15 (43%) of patients with PGTs compared with 37 (71%) of patients in the control group (P = .03). Nearly all patients who required a therapeutic G-tube lost significant amounts of weight during radiotherapy, with an average loss of 8.5 kg (Table 3). No other factor appeared to influence the degree of weight loss during treatment.

Unplanned treatment interruptions were required in 15 (17%) of patients (Table 4). An additional 29 patients had a planned break as part of the radiation therapy scheme. The need for an unplanned treatment break was not influenced by the use of a PGT (5 [15%] with PGT vs 10 [21%] without PGT). Furthermore, there was no difference in overall duration of radiation therapy between the group with PGTs (44.3 ± 7.1 days) and the control group (45.9 ± 10.9 days). Among patients with favorable performance status (Karnofsky score ≥80), there was a trend toward fewer radiotherapy interruptions in patients with a PGT than in those without a PGT (0 [0%] vs 9 [18%]; P = .08).

The rate of unplanned admissions for any reason did not differ by use of PGT (8 [26%] vs 20 [42%]; P = .15), site of the primary tumor, stage of disease, or initial performance status. There was no significant difference in rate of hospitalizations among patients receiving chemoradiation as compared with those receiving BID radiation therapy (12 [43%] vs 16 [27%]; P = .23). Twelve patients treated with chemoradiation were admitted for complications of mucositis (10 [83%]), acute renal failure (1 [8%]), or neutropenic fever (1 [8%]). Sixteen patients treated on a BID basis without chemotherapy were admitted for complication of mucositis (8 [50%]), pneumonia (3 [19%]), airway problems (2 [13%]), pain control (1 [6%]), gastrointestinal tract bleeding (1 [6%]), or an unknown reason (1 [6%]).

More than 70% of hospitalizations during treatment (n = 20) were primarily related to malnutrition or dehydration (Table 5). There were significantly fewer nutrition-related admissions among the patients with PGTs than among the control patients (13% vs 34%; P = .04). We identified no other risk factor that was significantly associated with the need for nutrition-related admission other than the lack of a PGT (Table 6). Even among patients with good performance status and no significant pretreatment weight loss, nutrition-related hospitalization occurred in 18% when they relied on oral feeding. During many of these hospitalizations, a G-tube was placed as a therapeutic measure. A total of 16 (31%) of 52 patients in the control group underwent G-tube placement either during or shortly after completing radiation therapy for malnutrition or dehydration. Weight loss of 4.53 kg or more during treatment was the only identifiable factor predictive of the need for a therapeutic G-tube (P = .01).

Only 4 patients with PGTs were admitted during their course of radiotherapy with nutritional or volume problems. These patients underutilized their G-tubes because of poorly functioning feeding tubes, intolerance to feedings, or lack of assistance with feedings. Complications related to PGT placement or utilization were rare. One patient with a PGT required hospitalization for a second procedure for revision of a malfunctioning tube. An additional patient required overnight intubation after G-tube placement likely because of sedative effects of anesthesia. Therapeutic G-tube placement was attempted in 2 patients during an unplanned break from radiotherapy but was unsuccessful. Overall, however, PGTs and therapeutic G-tubes were generally well tolerated and efficacious.

Overall 3-year survival was 45%. In multivariate analysis, only unfavorable performance status and higher stage of disease were identified as poor prognostic indicators; the use of PGTs had no influence on overall survival or local control.

Forty percent or more of patients with advanced cancers of the head and neck have some degree of malnutrition.¹⁹ Continued deterioration of nutritional status is multifactorial and commonly attributed to impaired swallowing secondary to tumor effects or after ablative surgery or resulting from toxic effects of radiation therapy, including xerostomia, loss of taste, and mucositis. Significant nutritional deficiency is readily detected by clinical examination and associated with poorer outcome.²⁰

Numerous nutritional support measures have been described for patients undergoing treatment for head and neck cancer. Oral supplementation^21,22 or temporary nasogastric tube feedings may stabilize patients' weights, improve nutritional indexes, or minimize breaks from radiotherapy. One prospective study randomly assigned 40 patients undergoing once-daily radiation therapy for advanced head and neck cancer to nasogastric tube feedings or oral feedings.²³ There was significantly less weight loss with nasogastric tube feedings (P<.04). No randomized trial has conclusively demonstrated improved local control or survival as a result of nutritional intervention before or during radiotherapy.

Nasogastric tube feeding is appropriate for short-term nutritional supplementation when oral intake is inadequate. Because nutritional supplementation may be required beyond the typical 6 to 8 weeks needed for radiotherapy of head and neck cancers, nasogastric tubes are unsuitable in this clinical setting.²⁴ Furthermore, patient discomfort, poorer cosmesis, risk of aspiration or sinusitis, greater frequency of occlusion, and effects of local irritation to irradiated mucosa make nasogastric tubes less attractive for head and neck cancer patients undergoing radiotherapy.^25,26

Gastrostomy tubes can be used either prophylactically or therapeutically via an endoscopic^13,14 or radiologically guided²⁷ approach. These are indicated for long-term nutritional supplementation when oral intake is inadequate secondary to either the local effects of tumor or toxic effects from treatment. The majority of reports describe the use of G-tubes postoperatively or in patients receiving palliative care for advanced or recurrent disease.

A prophylactic strategy can be used in patients undergoing radiotherapy for head and neck cancer. Studies have been limited to patients undergoing predominantly conventional once-a-day radiation therapy. One retrospective review demonstrated that planned preradiation nasogastric or gastrostomy tube feedings led to significantly less weight loss (4.8%) in patients with planned tube feedings than in those with only oral intake (7.1%) or with therapeutic tube feedings (9.4%).¹⁸ These results were corroborated by Tyldesley et al,¹⁷ who noted weight loss limited to 3% to 5% in patients with prophylactic feeding tubes compared with weight loss of 9% in matched controls.¹⁷ In 1 prospective study, 212 patients were randomly assigned to oral or G-tube feedings.¹⁶ Quality of life, body weight, prealbumin levels, and triceps skin fold measurements remained constant in 47 patients with PGTs and declined significantly in the orally fed patients.

Despite aggressive supportive measures, the overall unplanned hospitalization rate during intensive radiation therapy was considerably higher (36%) in our series than that experienced during conventional radiation therapy at our institution (8%).²⁸ We also observed a significant amount of weight loss during radiotherapy, with a mean difference of 5.3 kg, and the severity of weight loss was minimized with the use of PGTs. In addition, PGTs led to a significant reduction in hospitalizations for dehydration and weight loss, but had no effect on the rate of treatment breaks or hospital admissions for all causes. Selection bias to place PGTs in patients with less favorable performance status may confound results.

Percutaneous G-tube placement is generally safe and well tolerated; however, complications such as site infection or migration of the feeding tube do occur and are usually manageable with conservative therapy.²⁹ Nutritional compromise may contribute to a higher rate of complications,³⁰ including potential airway obstruction in patients with advanced disease.³¹ Enteral feeding tubes are not universally efficacious, as their use may be limited by gastrointestinal tract motility problems or by patient intolerance to feedings.²⁹ In this series, 4 of 52 patients suboptimally utilized their G-tubes and developed nutritional or volume-related problems. Finally, the rare complication of tumor implantation at the gastrostomy site has been described in case reports³² but was not observed in our patient cohort.

Concurrent chemoradiation and BID radiotherapy for head and neck cancer are intensive treatments associated with more frequent, more severe, and longer-lasting acute toxic effects. More than half of our patients used a G-tube either prophylactically or therapeutically. Prophylactic placement of G-tubes can significantly reduce the amount of weight loss during radiotherapy and the number of hospitalizations because of dehydration, weight loss, or other complications of mucositis. We routinely place elective PGTs in patients in whom higher-intensity radiation therapy is planned. Prospective studies will be necessary to determine the impact of such nutritional intervention on tumor control and overall survival.

Accepted for publication April 16, 1998.

We thank Rosemarie Mick, MS, for her assistance with the statistical analysis. The authors assume sole responsibility for the contents of the article.

Reprints: Mitchell Machtay, MD, Department of Radiation Oncology, 3400 Spruce St, 2 Donner, Philadelphia, PA 19104 (e-mail: machtay@xrt.upenn.edu).