Background
Methods
Patients
Treatment and follow-up
Percutaneous endoscopic gastrostomy placement
Definition of unplanned hospitalizations and follow-up
Toxicities and the course of body weight
Statistical analysis
Results
Characteristic | All patients (n = 310) | pPEG (n = 175) | nPEG or rPEG (n = 135) | P value |
---|---|---|---|---|
Age at first diagnosis, years | ||||
Median (range) | 61 (20–94) | 62 (20–83) | 61 (40–94) | ns |
≤ 60, n (%) | 139 (44) | 75 (43) | 64 (47) | ns |
> 60– ≤ 70, n (%) | 111 (36) | 36 (37) | 47 (35) | ns |
> 70– ≤ 80, n (%) | 45 (15) | 32 (18) | 13 (10) | .035 |
> 80, n (%) | 15 (5) | 4 (2) | 11 (8) | .029 |
Sex, n (%) | ||||
Female | 75 (24) | 129 (74) | 106 (79) | ns |
Male | 235 (76) | 46 (26) | 29 (21) | ns |
ECOG performance status, n (%) | ||||
0 | 112 (36) | 56 (32) | 56 (43) | ns |
1 | 153 (50) | 87 (50) | 66 (50) | ns |
2/3 | 40 (14) | 30 (18) | 9 (7) | .006 |
Missing, n | 5 | 1 | 4 | na |
Median (range) baseline BMI, kg/m2 | 24.9 (16.8–38.7) | 24.9 (16.8–38.6) | 24.9 (17.6–36.8) | ns |
Body weight loss during RT, CTCAE grade, n (%) | ||||
0 | 135 (47) | 92 (55) | 43 (36) | .002 |
1 | 87(30) | 48 (29) | 39 (33) | ns |
2 | 62 (22) | 26 (15) | 36 (30) | .004 |
3 | 2 (1) | 1 (1) | 1 (1) | ns |
Missing, n | 24 | 8 | 16 | na |
Smoking habits | ||||
Never smoker | 34 (13) | 21 (13) | 13 (12) | ns |
Ex-smoker | 75 (29) | 47 (30) | 28 (26) | ns |
Current smoker | 153 (58) | 87 (56) | 66 (62) | ns |
Missing, n | 48 | 20 | 28 | na |
Tobacco use, pack-years | ||||
Median (range) | 40 (0–150) | 40 (0–150) | 40 (0–120) | ns |
> 40 (i.e. above median), n (%) | 100 (44) | 65 (46) | 35 (41) | ns |
Missing, n | 83 | 34 | 49 | ns |
Alcohol abuse, n (%) | ||||
No | 85 (33) | 54 (35) | 31 (31) | ns |
In the past | 23 (9) | 15 (10) | 8 (8) | ns |
Yes | 147 (58) | 85 (55) | 62 (61) | ns |
Missing, n | 55 | 21 | 34 | na |
Tumor localization, n (%) | ||||
Oral cavity | 63 (20) | 36 (21) | 27 (20) | ns |
Oropharynx | 149 (48) | 77 (44) | 72 (53) | ns |
Hypopharynx | 44 (14) | 33 (19) | 11 (8) | .008 |
Larynx | 39 (13) | 16 (9) | 23 (17) | ns |
Multi-compartemental | 15 (5) | 13 (7) | 2 (2) | .016 |
Tumor category, n (%) | ||||
T1 | 25 (8) | 9 (5) | 16 (12) | .036 |
T2 | 95 (31) | 42 (24) | 53 (39) | .004 |
T3 | 102 (33) | 59 (34) | 43 (32) | ns |
T4 | 88 (28) | 65 (37) | 23 (17) | < .001 |
Nodal category, n (%) | ||||
N0 | 36 (12) | 17 (10) | 19 (14) | ns |
N1 | 55 (18) | 21 (12) | 34 (25) | .004 |
N2 | 206 (66) | 128 (73) | 77 (57) | .003 |
N3 | 11 (4) | 9 (5) | 5 (4) | ns |
UICC stage (7th edition), n (%) | ||||
III | 65 (21) | 22 (13) | 43 (32) | < .001 |
IVA | 228 (74) | 142 (81) | 86 (64) | < .001 |
IVB | 17 (5) | 11 (6) | 6 (4) | ns |
Surgical interventions, n (%) | ||||
Primary oncologic resection | 78 (25) | 42 (27) | 36 (27) | ns |
Neck dissection | 214 (69) | 121 (69) | 93 (69) | ns |
PEG tube placement, n (%) | ||||
Prophylactic | 175 (56) | 175 (100) | 0 (0) | na |
Reactive | 34 (11) | 0 (0) | 34 (25) | na |
None | 101 (33) | 0 (0) | 101 (75) | na |
Median (range) duration of PEG dependency, days | 266 (4–2969) | 274 (40–2969) | 231 (4–2554) | < .001 |
Chemotherapy, n (%) | ||||
Concomitant | 266 (86) | 161 (92) | 105 (78) | < .001 |
Neoadjuvant | 33 (11) | 21 (12) | 12 (9) | ns |
UH | No. of patients (%) | All UHs, no. of events (%) | |
---|---|---|---|
UH1 | UH2 | ||
Any UH | 141 (45) | 64 (21) | 205 events in 169 patients |
Reason for UH | |||
Comorbidity-related | 34 (11) | 16 (5) | 50 (24) |
Alcoholism | 4 (12) | 0 (0) | 4 (8) |
Cardiopulmonary | 9 (27) | 3 (19) | 12 (24) |
Gastrointestinal | 4 (12) | 0 (0) | 4 (8) |
Infection | 12 (35) | 5 (31) | 17 (34) |
Other | 5 (14) | 8 (50) | 13 (26) |
Related to tumor or relapse | 19 (6) | 14 (4) | 33 (16) |
Treatment-related (TRUH) | 88 (28) | 34 (11) | 122 (60) |
Due to PEG | 11 (13) | 1 (2) | 12 (10) |
Due to surgery | 3 (3) | 1 (3) | 4 (3) |
Due to neoadjuvant CX | 4 (4) | 2 (6) | 6 (5) |
Due to radio-CX | 70 (80) | 29 (85) | 99 (81) |
Reason for TRUH | All patients (n = 310) | pPEG (n = 175) | nPEG or rPEG (n = 135) | |||
---|---|---|---|---|---|---|
No | (%) | No | (%) | No | (%) | |
TRUH1 (n = 88) | ||||||
Dermatitis/mucositis/oral infection | 18 | (20) | 13 | (23) | 5 | (16) |
Dysphagia/dehydration/malnutrition | 15 | (17) | 7 | (12) | 8 | (26) |
General condition | 8 | (9) | 5 | (9) | 3 | (10) |
Osteonecrosis/dental caries | 8 | (9) | 5 | (9) | 3 | (10) |
Other | 11 | (11) | 7 | (13) | 4 | (13) |
Percutaneous endoscopic gastrostomy | 11 | (14) | 9 | (16) | 2 | (6) |
Pneumonia/dyspnea | 17 | (19) | 11 | (19) | 6 | (19) |
Total | 88 | (28) | 57 | (33) | 31 | (23) |
TRUH2 (n = 34) | ||||||
Dermatitis/mucositis/oral infection | 3 | (9) | 3 | (13) | 0 | (0) |
Dysphagia/dehydration/malnutrition | 1 | (3) | 1 | (4) | 0 | (0) |
General condition | 4 | (12) | 2 | (8) | 2 | (20) |
Osteonecrosis/dental caries | 6 | (18) | 3 | (13) | 3 | (30) |
Percutaneous endoscopic gastrostomy | 3 | (9) | 0 | (0) | 1 | (10) |
Pneumonia/dyspnea | 14 | (41) | 11 | (46) | 3 | (30) |
Other | 3 | (9) | 4 | (17) | 1 | (10) |
Total | 34 | (11) | 24 | (14) | 10 | (7) |
All TRUHs (n = 122) | ||||||
Dermatitis/mucositis/oral infection | 21 | (17) | 16 | (20) | 5 | (12) |
Dysphagia/dehydration/malnutrition | 16 | (13) | 8 | (10) | 8 | (20) |
General condition | 12 | (10) | 7 | (9) | 5 | (12) |
Osteonecrosis/dental caries | 14 | (11) | 8 | (10) | 6 | (15) |
Percutaneous endoscopic gastrostomy | 12 | (12) | 11 | (14) | 1 | (10) |
Pneumonia/dyspnea | 31 | (25) | 22 | (27) | 9 | (22) |
Other | 13 | (11) | 9 | (11) | 4 | (10) |
Total number | 122 | (–) | 81 | (–) | 41 | (–) |
Variable | TRUH1 | TRUH2 | OS | |||
---|---|---|---|---|---|---|
HR (95% CI) | P value | HR (95% CI) | P value | HR (95% CI) | P value | |
Univariate | ||||||
Age, years | ||||||
≤ 60 | 0.76 (0.48–1.18) | .21 | 0.74 (0.35–1.56) | .42 | 0.63 (0.42–0.96) | .0288 |
> 60–≤ 70 | 1.00 (0.64–1.58) | .99 | 1.07 (0.51–2.67) | .86 | 0.92 (0.60–1.40) | .6884 |
> 70–≤ 80 | 1.43 (0.82–2.50) | .20 | 1.59 (0.65–3.91) | .30 | 1.40 (0.84–2.34) | .1937 |
> 80 | 1.52 (0.61–3.75) | .35 | 0.80 (0.11–5.85) | .82 | 4.25 (2.26–7.99) | .0001 |
ECOG PS at first consultation, (vs other PS) | ||||||
0 | 0.95 (0.60–1.51) | .83 | 0.89 (0.41–1.91) | .76 | 0.64 (0.41–1.00) | .0475 |
1 (vs others) | 0.73 (0.47–1.14) | .16 | 0.59 (0.28–1.26) | .17 | 1.05 (0.71–1.58) | .7939 |
2/3 (vs others) | 1.99 (1.15–3.45) | .01 | 2.77 (1.23–6.27) | .01 | 2.01 (1.21–3.37) | .0061 |
Alcohol abuse | ||||||
Active | 1.16 (0.71–1.88) | .55 | 0.81 (0.36–1.83) | .60 | 1.23 (0.78–1.94) | .3783 |
Active or in past | 1.59 (0.92–2.75) | .09 | 1.17 (0.48–2.85) | .72 | 1.33 (0.82–2.16) | .2475 |
> 2 units a day (= median) | 1.44 (0.81–2.57) | .21 | 0.84 (0.30–2.35) | .73 | 1.06 (0.63–1.79) | .8203 |
Smoking habits | ||||||
Current smoker | 1.13 (0.70–1.82) | .61 | 0.94 (0.41–2.13) | .87 | 1.06 (0.68–1.66) | .7832 |
Current or ex-smoker | 1.68 (0.74–3.92) | .20 | 3.39 (0.46–25.1) | .20 | 1.14 (0.59–2.21) | .7022 |
> 40 pack-years (= median) | 1.94 (1.17–3.20) | .01 | 1.98 (0.81–4.85) | .12 | 1.01 (0.63–1.63) | .9615 |
Tumor localization, yes (vs no) | ||||||
Oral cavity | 1.06 (0.62–1.81) | .83 | 0.81 (0.31–2.12) | .67 | 0.80 (0.48–1.36) | .409 |
Oropharynx | 0.75 (0.48–1.17) | .19 | 0.75 (0.36–1.56) | .43 | 0.63 (0.42–0.95) | .026 |
Hypopharynx | 1.43 (0.81–2.50) | .20 | 2.00 (0.86–4.69) | .10 | 1.81 (1.11–2.93) | .0149 |
Larynx | 1.21 (0.66–2.23) | .53 | 0.79 (0.24–2.60) | .69 | 1.39 (0.81–2.38) | .2251 |
Mixed | 0.80 (0.25–2.52) | .69 | 1.60 (0.38–6.73) | .56 | 1.81 (0.74–4.48) | .1878 |
Surgery, yes (vs no) | ||||||
Primary oncologic surgery | 0.72 (0.42–1.24) | .22 | 0.47 (0.16–1.34) | .15 | 0.79 (0.49–1.29) | .3395 |
Neck dissection | 0.69 (0.44–1.07) | .09 | 0.47 (0.23–0.96) | .03 | 0.66 (0.44–0.99) | .0438 |
Bilateral ND | 1.69 (1.08–2.64) | .00 | 1.75 (0.84–3.67) | .13 | 0.92 (0.58–1.45) | .7161 |
Tracheostomy | 1.78 (1.15–2.77) | .01 | 2.58 (1.24–5.35) | .01 | 1.49 (0.98–2.25) | .0594 |
pPEG | 1.46 (0.93–2.30) | .09 | 2.56 (1.09–5.99) | .02 | 1.24 (0.82–1.86) | .3003 |
rPEG | 2.54 (1.48–4.33) | .00 | 1.75 (0.67–4.58) | .25 | 2.07 (1.25–3.43) | .0038 |
Chemotherapy, yes (vs no) | ||||||
Neoadjuvant | 1.53 (0.83–2.83) | .57 | 2.82 (1.20–6.60) | .01 | 1.26 (0.69–2.31) | .4535 |
Concomitant | 1.22 (0.61–2.43) | .16 | 2.08 (0.50–8.76) | .30 | 0.59 (0.35–1.02) | .054 |
Baseline BMI, kg/m2 | ||||||
≤ 18.5 | 1.11 (0.27–4.54) | .89 | 1.46 (0.20–10.8) | .71 | 3.42 (1.23–9.50) | .0115 |
> 18.5–< 25 | 0.70 (0.41–1.22) | .20 | 0.73 (0.30–1.73) | .46 | 0.94 (0.56–1.58) | .8135 |
≥ 25 | 1.39 (0.81–2.38) | .22 | 1.29 (0.55–3.02) | .55 | 0.88 (0.53–1.47) | .6231 |
Multivariate | ||||||
Model 1 for TRUH1 | ||||||
ECOG 2/3 | 1.73 (0.93–3.23) | .10 | – | – | – | – |
> 40 pack-years | 1.94 (1.17–3.20) | .01 | – | – | – | – |
Bilateral ND | 1.69 (1.02–2.78) | .04 | – | – | – | – |
Model 2 for TRUH2 | ||||||
ECOG 2/3 | – | – | 2.77 (1.23–6.27) | .03 | – | – |
pPEG | – | – | 2.06 (0.87–4.91) | .09 | – | – |
Neoadjuvant CX | – | – | 3.27 (1.38–7.74) | .02 | – | – |
Model 3 for OS | ||||||
Age > 80 years | – | – | – | – | 4.25 (2.26–7.99) | .00 |
ECOG 2/3 | – | – | – | – | 1.64 (0.94–2.85) | .10 |
rPEG | – | – | – | – | 1.95 (1.18–3.25) | .02 |