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Prophylactic Percutaneous Endoscopic Gastrostomy in Patients With Advanced Head and Neck Tumors Treated by Combined Chemoradiotherapy

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Prophylactic Percutaneous Endoscopic Gastrostomy in Patients With Advanced Head and Neck Tumors Treated by Combined Chemoradiotherapy
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  Original Article  Prophylactic Percutaneous EndoscopicGastrostomy in Patients With Advanced Headand Neck Tumors Treated by CombinedChemoradiotherapy  Eric Assenat, MD, PhD, Simon Thezenas, PhD, Nicolas Flori, MD,Nicole Pere-Charlier, MD, Renaud Garrel, MD, PhD, Antoine Serre, MD,David Azria, MD, PhD, and Pierre Senesse, MD, PhD  Department of Gastro-Nutrition (E.A., N.F, P.S.), Department of Biostatistics (S.T.), Department of  Anaesthesia (N.P.-C.), and Department of Radiotherapy (A.S., D.A.), Val d’Aurelle Cancer Institute; and Department of Head and Neck Surgery (R.G.), CHU Guy de Chauliac, Montpellier, France   Abstract  Context.  Few studies have evaluated outcomes of combined chemoradiotherapy for Stage III e IV head and neck squamous cell carcinoma in terms of the use of nutritional support by means of percutaneous endoscopic gastrostomy (PEG). Objectives.  To compare nutritional status and treatment interruption becauseof acute toxicity in patients with advanced head and neck tumors who were treatedby combined chemoradiotherapy and received or did not receive prophylacticPEG tubes. Methods.  This was a retrospective study that evaluated data obtained froma cancer center in Montpellier, France. A total of 139 consecutive patients treatedfor Stage III e IV head and neck squamous cell carcinoma from January 1, 1998 to June 30, 2003 were evaluated in terms of nutritional status before and aftertherapy, treatment interruption because of toxicity, and duration of hospitalization. Results.  Seventy-eight of the 139 patients (58%) did not receive prophylacticPEG feeding, and 61 patients (44%) received PEG feeding. Pretreatment nutritional status was worse in the PEG group. Compared with the initialnutritional status, nutritional status at the end of treatment was unchanged in thePEG group and much worse in the group that did not receive the PEG ( P  < 0.05).Cumulative incidence of treatment interruption because of toxicity wassignificantly lower in the PEG group than in the no-PEG group (100 and 236 daysof interruption, respectively,  P  ¼ 0.03) and hospitalization was significantly shorter( P  ¼ 0.003). Conclusion.  Prophylactic PEG sustains nutritional status and reduces thecumulative incidence of treatment interruption caused by toxicity and durationof hospitalization. A randomized study is warranted to validate these Address correspondence to:   Pierre Senesse, MD, PhD,DepartmentofGastro-Nutrition,CRLCVald’Aurelle,Parc Eurom  edecine, Rue de la Croix Verte, 34298Montpellier cedex 5, France. E-mail: psenesse@ valdorel.fnclcc.fr Accepted for publication: January 21, 2011.   2011 U.S. Cancer Pain Relief CommitteePublished by Elsevier Inc. All rights reserved.0885-3924/$ - see front matterdoi:10.1016/j.jpainsymman.2011.01.009 548 Journal of Pain and Symptom Management Vol. 42 No. 4 October 2011  results. J Pain Symptom Manage 2011;42:548 e 556.  2011 U.S. Cancer Pain Relief  Committee. Published by Elsevier Inc. All rights reserved. Key Words  Gastrostomy, chemoradiotherapy, enteral nutrition, acute side effects, head and neck neoplasms  Introduction  Headandnecksquamouscellcarcinomasarefrequent tumors, with more than 550,000 new cases of cancers in the oral cavity, oropharynx,hypopharynx, and larynx per year worldwide. 1 Severalstudieshaveshownthateatingproblemsand nutritional deficiencies are common inthesepatientsbeforetheonsetoftreatment. 2 e 4 Indeed,headandneckmalignanciesfrequently resultindecreasednutritionalintakebecauseof local (e.g., painful and impaired chewing andswallowing) or general symptoms (e.g., de-creased appetite and anorexia). The adverseeffects of this lower oral intake on body massare often rapidbecauseofthefrequentpreexis-tence of nutritional deficiencies consequent topersonal habits, excessive alcohol consump-tion, tobacco use, and long-standing inade-quate nutritional intake.In about 40% of patients with head and neckmalignancies, the disease is locally advanced at diagnosis. In these cases, multimodal therapy (surgery, radiation therapy, and chemother-apy) has been used for decades to achieve localand regional control. Radiation therapy is usedin the treatment of two-thirds of head andneck cancers, and to preserve these organs, in-tensive radiation regimens combined with che-motherapy are required. 5,6 Mostpatients(41% e 62%)whoreceiveache-moradiotherapyprotocoldevelopseveremuco-sitis lasting from one to three months. 5 e 7 Mucositis represents a painful dose-dependent side effect, which can lead to reduced oral in-take, and subsequently, to impaired nutritionaland general performance status, lower t reat-ment tolerance, and poorer quality of life. 8 e 10 Todate,thereisnowidelyacceptedprophylaxisor effective curative treatment for radiation-induced mucositis, and the clinical manage-ment of this problem is a major challenge. 11 e 14 Inonestudy,forexample,mucositisoccurredin89% of patient s, with Grade 3 or 4 severity in43% of cases. 14 Maintaining acceptable nutritional statusthroughout an adjuvant or classic course of combined chemoradiotherapy is difficult inthe presence of mucositis. According to theEuropean Society for Clinical Nutrition andMetabolism guidelines on enteral nutrition of patients with external beam radiotherapy orchemoradiotherapy, every effort should bemade to increase dietary intake, prevent muco-sitis,andavoidinterruptionofchemoradiation.In patients with head and neck tumors treatedby radiotherapy, dietary counseling reducesthe incidence and severity of toxicities andimproves quality of life, but when mucositis ismore likely to be severe, as it is with combinedtherapy, counseling is not sufficient. Enteralfeeding through a percutaneous endoscopicgastrostomy (PEG) is used in some centers toaddress the nutritional needs of patients inthis situation, but there is no Phase III random-ized controlled trial comparing gastrostomy  with other artificial nutritional support.Recently, however, a randomized, controlled,open comparison of systematic percutaneousgastrostomy vs. no systematic gastrostomy sug-gested that prophylactic gastrostomy improvespost-treatment quality of life f or unresectablehead and neck cancer patients. 15 In this study, we report our institutionalexperience in the use of prophylactic PEGplacement in patients with advanced headand neck cancer. We discuss the impact of the prophylactic PEG placement on nutri-tional status, treatment interruption becauseof toxicity, and duration of hospitalization. Methods  Participants  Between 1998 and 2003, 1231 patients withhead and neck tumors were managed at theMontpellier comprehensive cancer center(313 patients were treated by surgery alone,139 by combined chemoradiotherapy, 257 by  Vol. 42 No. 4 October 2011 549 Prophylactic PEG Before Chemoradiotherapy of Head and Neck Tumors   radiotherapy alone, and 449 had follow-upconsultations). Medical records and nutri-tional data were retrospectively reviewed from139 consecutive patients treated between1998 and 2003 by curative combined chemora-diotherapy for locally advanced (Stage III or IV squamous cell) head and neck carcinoma(without metastasis). All patients had a life ex-pectancy greater than three months anda World Health Organization performance sta-tus of 0, 1, or 2. Tumors were staged accordingto the 1997 TNM classification based on thephysical examination, endoscopic evaluation,and computed tomography findings. Foreach case, localization and differentiation of the tumor were noted. Nutritional Management  There were two distinct periods regardingthe nutritional management of head andneck cancer patients in our institution. In thefirst period from 1998 to 2001, the patientsdid not receive PEG tubes before combinedchemoradiotherapy. Because outcomes interms of the need for parenteral nutrition,hospitalizations, and interruption of treatment appeared to be relatively poor, we started a pro-gram to place prophylactic PEG tubes beforecombined chemoradiotherapy. Specifically, inthesecondperiod (2001 e 2003),aprophylacticPEG was systematically proposed in cases of odynophagia, malnutrition (defined by weight loss  $ 5% at one month or  $ 10% at sixmonths, Nutritional Risk Index 16 < 83.5, oralbuminemia  < 30 g/L), or bifractionatedradiotherapy. PEG insertion was performedby the same physicians (E. A. and P. S.) with the ‘‘pull’’ technique under propofolanesthesia before the beginning of combinedchemoradiotherapy and during a short hospi-talization. To prevent wound infection, weused antibiotic prophylaxis, abdominal shav-ing for men, and cutaneous sterilization withpovidone iodine.In all cases, a medical evaluation was per-formed by two physicians (E. A. and P. S.).Malnutrition was systematically documentedby weight loss, serum albumin dosage, andNutritional Risk Index. All patients wereencouraged to maintain an oral diet and re-ceived dietary counseling (oral supplementa-tion) at the initial evaluation and during thetreatment. Estimated energy requirements were calculated on the basis of the Harris-Benedict equation, with a corrective factor of 1.3. The same physicians, specialists in nutri-tion, did parenteral or enteral nutrition. Forthe group that underwent PEG insertion(PEG group), enteral feeding was performedimmediately in patients who met malnutritioncriteria before the beginning of the treatment or when oral intake was less than 60% as com-pared with before treatment. Enteral feedingconsisted of a polymeric isocaloric diet, admin-istered continuously by a pump during thenight, and oral feeding was encouraged when-ever possible. In case of severe dysphagia withpain and/or dehydration in patients of theno--PEG group, we proposed an oral supple-mentation, and when oral intake was lessthan 60%, parenteral nutrition was deliveredthrough the central venous access. Nutritionaloutcomes were measured from Day 1 of treat-ment until the end of artificial nutrition. Oncologic Treatment   All patients were treated by combined che-moradiotherapy. Radiotherapy was delivered with a three-field (anterior and opposed lat-erals) isocentric technique. One hundred sixpatients (76.3%) received a daily fraction of 1.8 Gy, five days a week, with a total radiother-apydoseof70 Gy,andthreecoursesofcisplatin(100 mg/m 2 of cisplatin at Days 1, 21, and 43).Theothers(37.3%)wereincludedinaprospec-tive study and received twice-daily hyperfractio-nated radiotherapy of 1.2 Gy/day, five days per week, with total tumor doses of 80.4 Gy/46 day (oropharynx), and 75.6 Gy/44 day (hypophar- ynx). 17 Patients received chemotherapy by cis-platin 100 mg/m 2 (Days 1, 22, and 43) and5-fluorouracil during radiotherapy (750 mg/m 2 /day as a five day-long continuous infusion,Cycle 1; 430 mg/m 2 /day, Cycles 2 and 3). Che-motherapy was given for three cycles. Cisplatintherapy was postponed if, on the day of treat-ment, the neutrophil count was below 1000/mm 3 or the platelet count was below 75,000/mm 3 , or if the creatinine clearance droppedto50 mL/minute.Whenthesecondcycleofcis-platin was delayed, the third cycle was dropped. Side Effects and Follow-up   All patients were followed up weekly duringcombined chemoradiotherapy. Nutritionalevaluation was carried out by either medical 550 Vol. 42 No. 4 October 2011Assenat et al.  examination or dietary counseling. Enteral nu-trition tolerance and PEG were systematically evaluated. Treatment side effects were assessedby a radiotherapist every week according to theNational Cancer Institute Common Toxicity Criteria scale version 2.0 (radiation dermatitis,head and neck, and gastrointestinal mucosi-tis). Data concerning oncologic treatment toxicities, treatment interruption, and hospi-talization because of combined chemoradio-therapy were collected. Duration of hospitalstay for other reasons was excluded from thestatistical analysis (social reasons or transporta-tion problems). Overall survival and disease-free survival data also were collected. Statistical Methods  Categorical data were compared using aChi-squared test. Continuous data were charac-terized by median (extremes, minimum tomaximum) and compared using the Wilcoxonrank sum test. Survival rates were calculatedusing the Kaplan-Meier method and were ex-pressed with standard errors. Curves were com-pared using the log-rank test. Values less than0.05 were considered statistically significant.Data were analyzed using the Stata 7.0 pro-gram (StataCorp LP, College Station, TX). Results  Patients  Patients’ characteristics are summarized inTable 1. A PEG was inserted in 61 of the 139patients (43.9%) included in this study.Median age was 51.9 years in the PEG groupand 55 years in the no-PEG group ( P  ¼ 0.07).Men were predominant in both groups(83.6% and 82.1%, respectively). Tumor stage,initial location, and differentiation were com-parable in the two groups. Regarding the treat-ment, 59.3% of the patients received threecycles of chemotherapy, 32.5% two, and 8.1%only one. Ninety-five percent of the patientsreceived the prescribed dose of radiotherapy.Hyperfractionated radiotherapy was more fre-quent in the PEG group (32.8% vs. 16.7%)( P  ¼ 0.03). Nutritional Considerations  Nutritional status was initially worse in thePEG than in the no-PEG group (Table 2):serum albumin was lower (36 vs. 40 g/L, re-spectively;  P  < 0.0001), weight loss was larger(5 vs. 2 kg, respectively;  P  < 0.0001), and Nutri-tional Risk Index was worse (91.5 vs. 101.2; P  < 0.0001). However, at the end of the treat-ment, nutritional status in the no-PEG group was poorer, with an average loss of 5 kg( extremes  ,  20 to þ 2) and a 10-point reductionin the Buzby’s index ( extremes  , 67.2 to 109),than in the PEG group, where it did not change ( P  < 0.05).PEG was used for enteral artificial nutritionin 95% of the patients who received one. Nocomplications occurred during the periopera-tive procedure, and enteral nutrition was welltolerated. Only six of the 61 patients (4.3%) with a PEG experienced late complication be-cause of the gastrostomy (abdominal pain orinfection), and only one developed a wall ab-scess, which required chemotherapy discontin-uation. No diarrhea, aspiration syndrome,gastrostomy obstruction, or peristomial metas-tases were noted during the follow-up. Whenoncologic treatment was over (and only if thepatient showed adequate oral intake), thePEG was removed during a consultation(‘‘cut and push’’ method) in 78.6% of the casesor by endoscopy in 21.4% of the patients, with-out any complications.In the no-PEG group, parenteral nutrition was used in 45 patients (57.7%), associatedor not with oral supplementation. A total of 70 patients (89.7%) received oral supplemen-tation in this group. Seven cases of central venous access infection occurred in this group.No deaths linked to the nutritional support method were noted in either group. Oncologic Treatment  Sixty-nine patients (49.6%) underwent treat-ment interruption because of side effects. Themean duration was 4.8 days per patient. Inter-ruptions,durationofinterruptionfortoxicities,andcumulativeduration(days)oftreatmentin-terruption for toxicity were significantly lowerin the PEG group ( P  ¼ 0.01,  P  ¼ 0.003, and P  ¼ 0.03, respectively) (Table 3). Radiotherapy  was interrupted for a total of 488 days: 152daysbecauseofexternalcauses(machinemain-tenance or breakdown, official holiday, and pa-tient absence) and 336 days for side effects. Whereas the duration of interruption causedby days off was not different in the two groups, Vol. 42 No. 4 October 2011 551Prophylactic PEG Before Chemoradiotherapy of Head and Neck Tumors   cumulative duration of treatment interruptionfor toxicity was less frequent and shorter(100 vs. 236 days, respectively) in the PEGthan in the no-PEG group.  Follow-Up   All patients were followed up for a medianduration of 2.9 years ( extremes  , 2 e 4.4). Medianglobal survival was 1.99 years (95% confidenceinterval [CI], 0.84 e 5.49). Survival rates were 69% (95% CI, 60.6 e 76.1) at one year,49% (95% CI, 40.5 e 58.1) at two years, 41.5%(95% CI, 34.5 e 51.1) at three years, and 34%(95% CI, 25.3 e 44.2) at five years. No statisticaldifferences were observed between the twogroups regarding the overall survival and thelocal, regional, or metastasis recurrence rates. Discussion  In this study, we report our institutional expe-rience with prophylactic PEG insertion beforebeginning combined chemoradiotherapy in pa-tientstreatedforheadandnecktumors.Prophy-lactic gastrostomy was introduced in our centerto reduce treatment interruptions caused by either undernutrition or the occurrence of nu-tritional complications requiring interventions(such as parietal abscess or catheter-relatedinfections of central venous catheters). Table 1 Patient Characteristics  Variable  n  Prophylactic Gastrostomy,  n   (%) P  -value With Without Total number of patients 139 61 (43.9) 78 (56.1)Sex 0.81Male 115 51 (44.3) 64 (55.7)Female 24 10 (41.6) 14 (58.4) Age, years 0.07 < 60 111 53 (47.7) 58 (52.3) $ 60 28 8 (28.6) 20 (71.4)T 0.56T1 4 1 (25.0) 3 (75.0)T2 18 5 (27.8) 13 (72.2)T3 61 23 (37.7) 38 (62.3)T4 44 21 (47.7) 23 (52.3)TX 2 1 (50.0) 1 (50.0)N 0.91N0 27 12 (44.4) 15 (63.6)N1 112 49 (43.7) 63 (66.3)M 0.59M0 133 59 (44.4) 74 (55.6)M1 6 2 (33.3) 4 (66.7)Stage 0.67Stage 3 37 15 (40.5) 22 (59.5)Stage 4 102 46 (45.1) 56 (54.9)Differentiation 0.19Good 41 11 (26.8) 30 (73.2) Average 38 19 (50.0) 19 (50.0)Poor 17 7 (41.2) 10 (58.8)Unknown 43 24 (55.8) 19 (44.2)Location 0.14Oropharynx 59 30 (50.8) 29 (49.2)Oral cavity 14 7 (50.0) 7 (50.0)Hypopharynx 39 11 (28.2) 28 (71.8)Panpharynx 27 13 (48.1) 14 (51.9)Radiochemotherapy 0.03Conventional and CDDP 106 41 (38.7) 65 (61.3)Hyperfractionated and 5FU/CDDP 33 20 (60.6) 13 (39.4) CDDP ¼ cisplatin; 5FU ¼ fluorouracil. 552 Vol. 42 No. 4 October 2011Assenat et al.
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