• Computed tomography;
  • chemotherapy;
  • tumour volume;
  • surgery;
  • germ cell tumour


  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. References
  8. Authors

Objective To assess whether the response visible on computed tomography (CT) 21 days after the first course of chemotherapy in patients with nonseminomatous germ cell tumour predicts the need for surgery and whether three-dimensional (3D) reconstruction adds to the diagnostic accuracy.

Patients and methods CT scans from 52 patients treated with cisplatin-based chemotherapy were assessed for tumour shrinkage by measuring the changes of a one-dimensional (1D) measurement of the maximum transverse diameter, and comparing CT scans before, 21 days after the first course and at the end of chemotherapy (1D method). In a subset of patients, using a special formula, the 1D-derived 2D and 3D shrinkage (2Dder and 3Dder) were compared with four other computed or calculated methods (1D, 2D, 3Dcalc, 3Dcomp).

Results At day 21, in 32 of 52 patients (62%) there was < 50% tumour shrinkage using the 1D assessment; 21 of them (66%) needed surgery, compared with none of the 20 patients with > 50% tumour shrinkage by day 21 (χ2 = 22.83, P < 0.001). The 1D method showed significantly less shrinkage than all the other methods but when this was used to derive a 3D shrinkage, assuming the mass to be spherical (3Dder), it was not statistically different from that of 3Dcomp.

Conclusions The assessment of the response from 1D CT scan estimates 21 days after initiating chemotherapy identifies a subgroup of patients who have a high probability of needing surgery. Although expected to be more accurate, the 3Dcomp estimate of tumour shrinkage was no better than the 3Dder estimate.


  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. References
  8. Authors

Using bleomycin, etoposide and cisplatin (BEP), 80–85% of patients with metastatic nonseminomatous germ cell tumour (NSGCT) achieve a durable long-term cure with four courses [1–3]. Poor-risk patients with stage 1 NSGCT, with a 50% risk of relapse, achieve a 99% cure rate after two courses [4,5]. Despite this success, chemotherapy has some dose-related toxicity [6]. Although lethal toxicity is rare, pulmonary toxicity from bleomycin is the commonest effect and causes half the treatment-related deaths [1]. A less frequent lethal toxicity is secondary leukaemia associated with etoposide. Although it only develops in 0.5–0.7% of those receiving < 2 g/m2[7,8], it is too early to assess the possible risk of solid tumour development [9].

Surgical staging after chemotherapy with resection of residual masses is used to establish when it is safe to stop chemotherapy [10,11] and, if complete, can produce durable survival in patients failing chemotherapy [12,13]. Some authors have suggested that it may be necessary to operate on all patients to detect small-volume teratoma [14], although this is difficult to justify as these operations are far from risk-free and 85% show no viable cancer [10–14]. There have been several attempts to improve the selection of patients for surgery [15,16] and tumour shrinkage at 3 months after chemotherapy was considered an important predictor of necrosis.

Prompted by the increasing need for surrogate endpoints to monitor the safety of reducing treatment from four to three courses in good-risk patients [17], our unit investigated the use of estimated tumour shrinkage 21 days after the first course of chemotherapy as a predictor of the need for surgery [18]. This report updates these observations and examines whether recently developed three-dimensional (3D) volume estimates improve the identification of those needing surgery.

Patients and methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. References
  8. Authors

The medical records of 52 patients (22 previously reported [18] and 30 new patients with NSGCT), treated with primary cisplatin-based chemotherapy (between February 1991 and February 1997) and assessed using CT 21 days after the first course, were reviewed retrospectively. The inclusion criteria comprised: histologically confirmed NSGCT stage 2, 3 and 4 disease; treatment with cisplatin-based primary chemotherapy; normal tumour markers (AFP, hCG) after chemotherapy; availability of either all three measurements of the maximum transverse diameter (MTD) of the tumour, i.e. before chemotherapy (MTDpre) that on day 21 (MTD21), and that after chemotherapy (MTDpost), or response assessments in the hospital database system. Details of the staging and treatment were published elsewhere [2,19]. Patients were treated with cisplatin-based primary chemotherapy and received three to four courses of a locally developed modification of the original BEP regimen given over 3 days (EBCi3) [2]. The criterion for surgery after chemotherapy was the presence of any residual mass with a MTD of geqslant R: gt-or-equal, slanted 20 mm after the last chemotherapy course.

The first 23 previously reported patients [18] were scanned using the 350 Tomoscan (Philips, The Netherlands). The more recent 30 patients were staged using a high-speed spiral CT scan. Oral contrast medium (2% Gastrografin, Schering Plough, UK) was given to delineate the small bowel 1 h before the investigation, and 100 mL of Omnipaque 300 (Nycomed, Birmingham, UK) was injected intravenously during scanning. After this initial CT scan before chemotherapy, for each patient a limited scan only through the site of maximum disease was taken 21 days after the start of the first course of chemotherapy, to assess the early tumour shrinkage by treatment. A third scan was taken 4–6 weeks after completing the last course of chemotherapy, to calculate the overall tumour shrinkage. Corresponding early and overall responses to therapy in terms of tumour shrinkage were calculated for each patient using this one-dimensional (1D) method ( Table 1).

Table 1.  Methods of calculating the tumour shrinkage indices
Shrinkage indexDefinition
  1. MTA, maximum transverse area; TVcomp, tumour volume computed by 3D computer reconstruction; TVcalc, tumour volume calculated as MTA × height of the tumour.

Early (1D) Overall (1D) 100 × (MTDpre– MTD21)/MTDpre 100 × (MTDpre– MTDpost)/MTDpre
Early (2D)100 × (MTApre– MTA21)/MTApre
Overall (2D)100 × (MTApre– MTApost)/MTApre
Early (3Dcomp) 100 × (TVcomp pre– TVcomp21)/TVpre
Overall (3Dcomp) 100 × (TVcomp pre– TVcomp post)/TVcomp pre
Early (3Dcalc) 100 × (TVcalc pre– TVcalc21)/TVcalc pre
Overall (3Dcalc100 × (TVcalc pre– TVcalc post)/TVcalc pre
2Dder1 –[(1 − 1D shrinkage)2]
3Dder1 –[(1 − 1D shrinkage)3]

In a randomly selected subgroup of 11 patients, for 25 different CT measurements, 3D reconstructions were made and tumour volumes computed using special software previously validated using Plasticine phantoms (correlation coefficient 0.99) [20]. In addition to early and overall shrinkage (1D), other variables were also calculated using the formulae shown in Table 1. An early or overall positive response to therapy was defined as a geqslant R: gt-or-equal, slanted 50% tumour shrinkage, with < 50% reduction considered as no response.

Additionally, using 1D data, 2D and 3D shrinkage estimates were derived (2Dder and 3Dder) using the formulae also listed in Table 1 and which were developed from the data presented in the analysis supporting the use of 1D assessment by the National Cancer Institute Clinical Trial review group [21]. These formulae assume that the tumour is spherical.

The proportion of patients needing surgery in different groups according to response status (geqslant R: gt-or-equal, slanted 50% vs < 50% shrinkage) was evaluated using χ2 analysis. The phi coefficient was computed to show the strength of the bivariate relationship between need for surgery and response. After transformation to normality using the arcsine method, the tumour shrinkage assessed by 1D, 2D, 3Dcalc and 3Dcomp methods were compared by a repeated-measures anova with Bonferonni correction. This analysis included the timing of CT scanning as a within-patient factor and the patients and type of CT shrinkage assessment as between-patient factors. The skewed data from volume measurements by the 3Dcalc and 3Dcomp methods were logarithmically transformed to normality and then analysed using a paired t-test. The 1D tumour shrinkage of the two response groups were compared using an unpaired t-test. All tests of significance are given as two-tailed P-values, with the results considered statistically significant at P < 0.05.


  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. References
  8. Authors

The characteristics of the 22 earlier and 30 new patients recruited since 1995 are summarized in Table 2. For the analysis of response, the data from the new were pooled with those from the 22 previously reported patients. Of the 52 patients evaluated by the 1D method from the day 21 CT scan, 20 (38%) were responders and 32 (62%) were not. The proportion of patients undergoing surgery is shown in Table 3. An example of the degree of response that can occur by 21 days is shown in Fig. 1.

Table 2.  The characteristics of the patients
CharacteristicNew seriesPrevious series
Number of patients3022
Median (range) age, years34.5 (20–44)29 (24–37)
Disease stage, n (%)
 218 (60)14 (64)
 312 (40)3 (14)
 45 (22)
Median (range) MTD, cm
 Before2.8 (1.0–17.0)4.0 (2.0–9.0)
 Day 212.0 (0.0–17.0)1.0 (0.0–8.0)
 After1.2 (0.0–17.0)0.0 (0.0–5.0)
Surgery, n (%)
 Yes14 (47)7 (32)
 No16 (53)15 (68)
Surgery type
Histology of resected mass
 Teratoma8 (57)5 (72)
 Fibrosis and necrosis4 (29)1 (14)
 Carcinoma2 (14)1 (14)
Tumour histology
 Teratoma23 (77)16 (73)
 Other NSGCT7 (23)6 (27)
 Alive, NED29 (97)20 (90)
 Dead from disease1 (3)1 (5)
 Alive with disease1 (5)
Median (range) shrinkage (1D), %
 Early33 (− 58 to 100)60 (0–100)
 Overall50 (− 19 to 100)100 (− 66 to 100)
Table 3.  The relationship between the response ( > 50% shrinkage) as assessed by a CT on day 21 and after chemotherapy using the 1D method, and the need for surgery
ResponseTotal no. (%) of patientsPatients proceeding to surgery
Day 21 and overall responders20 (38) 0 (0)
Day 21 nonresponders but overall responders12 (23) 3 (25)
Day 21 and overall nonresponders20 (38)18 (90)
Day 21 responders and overall nonresponders 0 0
Total52 (100)21 (40)

Figure 1. CT scans a, before, b, after 21 days and c, at the end of chemotherapy, showing a para-aortic nodal mass and its response to chemotherapy.

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None of the early responders and 21 (66%) of the early nonresponders underwent surgery. Early response to chemotherapy was associated with significantly less need for surgery (χ2 = 22.83, P < 0.001). The correlation between early treatment responsiveness and need for surgery was strong (phi = 0.61, P < 0.001). When evaluated at the completion of chemotherapy for overall response, 32 of 52 (62%) patients had > 50% tumour shrinkage. Three of the 32 overall responders (9%) and 18 of 20 overall nonresponders (90%) needed surgery and the difference between them was significant (χ2 = 34.08, P < 0.001). The correlation between overall responsiveness and need for surgery was also strong (phi = 0.80, P < 0.001). Evaluated together, the early and overall responses assessed by CT on day 21 and after chemotherapy, and the proportion of patients proceeding to surgery are shown in Table 2.

The median overall 1D shrinkage at the completion of chemotherapy was 38% for early nonresponders, compared with 74% in early responders ( Fig. 2). The difference between the transformed variables was significant (P = 0.003).


Figure 2. The overall 1D shrinkage at the completion of chemotherapy in 30 patients with an early response. Negative shrinkage values indicate an increase in tumour size. The line represents the median, the box the 25–75th percentiles and the bars the range, excluding outliers (values > 1.5 × the limits of the box).

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In a subgroup of 11 patients with a total of 22 separate lesions, the CT images were reformatted in 3D to measure total tumour volume. For this subgroup, Table 4 shows the summary data for tumour shrinkage of the whole group of 22 lesions in 12 patients with the timing of CT and the method of tumour bulk assessment. The 1D method of assessing tumour shrinkage gave significantly different values from the 2D, 3Dcomp, 3Dcalc, 2Dder and 3Dder methods on day 21 ( Table 5), and only from the 3Dcomp and 3Dder after chemotherapy. Overall, the shrinkage assessment methods were significantly different (P = 0.001) but the 2D, 3Dcomp and 3Dder methods were not different from each other both on day 21 and after chemotherapy ( Table 5).

Table 4.  Summary values for the percentage tumour shrinkage according to the type and timing of assessment (11 patients,22 lesions)
Type of tumour bulk assessment Timing of CT
Day 21After chemotherapy
Median (range) tumour shrinkage (%)
 1D20 (0–49)23 (− 17 to 75)
 2D52 (− 24 to 80)72 (36–93)
 2Dder36 (0–74)77 (31–94)
 3Dder49 (0–87)89 (43–98)
 3Dcomp55 (− 30 to 83)86 (40–93)
 3Dcalc59 (44–86)90 (56–97)
Table 5.  Multiple comparisons with Bonferroni correction of the various methods of estimating tumour shrinkage (calculated using arcsin transformed variables); not all comparisons are shown, to save space
Shrinkage estimate Mean difference ( sd) [95% CI]
Day 21
1D−16.33 (0.74)−16.96 (0.74)−7.74 (0.85)−11.97 (0.74)−20.16 (0.74)
[−20.24 to −12.42][−20.87 to −13.05][−12.19 to −3.28][−15.8 to −8.06][−24.07 to −16.26]
P< 0.001< 0.0010.004< 0.001< 0.001
3Dcomp0.63 (0.74)9.22 (0.85)4.99 (0.74)−3.21 (0.74)
[−3.28 to 4.54][4.76–13.68][1.08–8.90][−7.11 to 0.70]
After chemotherapy
1D−14.78 (3.46)−18.61 (3.46)−16.67 (3.95)−13.73 (3.46)−21.92 (3.46)
[−32.96 to 3.41][−36.79 to −0.43][−37.40 to 4.06][−31.91 to 4.45][−40.10 to −3.73]
3Dcomp3.83 (3.46)1.93 (3.95)4.88 (3.46)− 3.31 (3.46)
[−14.35 to 22.01][−18.80 to 22.66][−13.30 to 23.06][−21.49 to 14.87]
1 111

The anova model assessed how the timing of CT scanning (day 21 vs after chemotherapy), type of CT scanning and the variation between patients affected the amount of tumour shrinkage; all three factors were significant (P leqslant R: less-than-or-eq, slant 0.001 for all). The 2D and 3D shrinkages derived using the formula from 1D data (2Dder and 3Dder) when assessed after chemotherapy were no different from those of 2D and 3Dcomp methods, respectively. However, on day 21, the 2Dder differed from 2D estimates, but the 3Dder did not differ from the 3D method (P = 0.031 and P = 0.115, respectively; Table 4 and 5).

Two approaches were used to attempt to validate the radiological findings. In nine patients, the residual mass was removed surgically and the 1D dimensions of the surgical specimen compared with the 1D measurement from the CT scan after chemotherapy ( Fig. 3). There was a consistent trend for the CT-estimated size to be less than the pathology sample size, although the mean (range) difference was only 27 (0–43)%.


Figure 3. A scatter plot of the difference in MTD after chemotherapy or after surgery in nine patients.

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In a separate set of experiments, the computer software used to determine TVcomp ( Table 1) was validated using Plasticine phantoms and gave a high correlation (data not shown). In the final assessment, TVcalc and TVcomp of 25 lesions in the same subgroup of 11 patients were also compared. The median TVcalc and TVcomp were 26 cm3 and 14 cm3, respectively. Tumour volumes assessed by these two methods were significantly different from each other (P < 0.001).


  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. References
  8. Authors

The optimal criteria for selecting patients for surgery after chemotherapy remains controversial in NSGCT [22,23]. The present study shows that an early response to chemotherapy, as assessed by CT on day 21 (1D method), and subsequent tumour marker normalization, can provide valid predictions for selecting a subgroup of patients for whom surgery may be safely avoided and the amount of chemotherapy given reduced from four to three courses [24]. Furthermore, in the UK, where delays can occur because of waiting lists, the 21-day CT information has obvious advantages in terms of booking dates for surgery for those not responding, irrespective of marker status [13]. Although the cost, both financial and from the radiation dose of an extra scan, must be considered in assessing the value of this strategy, the small radiation exposure (because the scanning is only limited to the major mass) and the avoidance of contrast medium make this a minimal procedure.

Although an early response to chemotherapy translated well into an overall response, the tumours in 28% (nine of 32) patients not responding by day 21 subsequently shrank to complete remission and the patients avoided surgery. The 3Dcomp method of assessing tumour volume was examined to try to improve on this proportion; the results suggested that the calculated method overestimated the volume of each metastasis by 77–86%, depending on whether the mean or median value was used. A similar value was reported in the only other previous study on this issue [25]. Improving the accuracy of tumour measurement could be important, as most of the published resection policies consider the tumour bulk of residual masses or those remaining after chemotherapy [15,26–29]. Clearly, more patients and additional surgical validation must be assessed before the TVcomp can be incorporated into such a resection policy, although the present results are not very encouraging.

Although the 1D method appeared to be accurate for assessing tumour bulk compared with large masses resected at surgery ( Fig. 3), overall, the 1D method underestimated tumour shrinkage compared with the 2D, 3Dcomp and 3Dcalc methods. A recent analysis reported by the National Cancer Institute Cancer Clinical Trial review group [28] provided some support for the safety of using the 1D response, although they recommend only using a 30% rather then a 50% decrease in MTD. In the present study, using a similar methodology, the 3Dder appeared as accurate as the 3Dcomp method.

To date there has been considerable variability in published resection policies for NSGCTC; they have predominantly focused on the size of the residual mass, histology of the primary tumour, the size of the mass and level of tumour markers before chemotherapy, and overall shrinkage of the tumour after 3 months of chemotherapy. These resection policies suggest resection of the original mass under the following conditions: residual masses of geqslant R: gt-or-equal, slanted 10 mm [26] or geqslant R: gt-or-equal, slanted 20 mm [27]; residual masses of geqslant R: gt-or-equal, slanted 10 mm or primary tumour teratoma positive [28]; residual masses of geqslant R: gt-or-equal, slanted 10 mm or prechemotherapy mass geqslant R: gt-or-equal, slanted 30 mm; residual masses of geqslant R: gt-or-equal, slanted 20 mm or primary tumour teratoma positive or elevated prechemotherapy AFP/hCG [10,29]; and shrinkage by leqslant R: less-than-or-eq, slant 70% or primary tumour teratoma positive [15]. Another model proposed by Steyerberg et al.[16] considers the estimate of residual tumour histology. As none of these policies has included an early response in the decision-making process, the present study clearly justifies further evaluation of the day 21 CT approach.

Apart from the practical perspective that early knowledge of the need for surgery after chemotherapy offers guidance in planning operating lists, more sophisticated software can now show relationships with other organs and major blood vessels, e.g. the inferior vena cava and aorta. This would help in increasing the safety of surgery. In addition, a day 21 CT scan, by detecting early unresponsiveness to chemotherapy, may also identify patients who would benefit from an early change of chemotherapy. With the increasing number of salvage strategies now available [30,31], this is increasingly relevant. In addition, there is an increasing need to develop a safe approach to avoid cumulative serious side-effects of the chemotherapy used in treating NSGCT, some of which may be life-threatening and dose-related, e.g. leukaemia [7,8] and bleomycin lung [32].

Confirming the safety of risking less treatment for patients but still producing a high cure rate is more difficult than improving the cure rate of patients with a low chance of cure [33]. If the present results could be validated more precisely, it might be possible to extend the observations and use them to quantify the effects of new drugs. Had the day 21 CT assessment been routine, it is possible that it might not have taken 12 years to determine that carboplatin is 10–15% less effective then cisplatin [34] or that it is not safe to omit bleomycin from the standard BEP regimen [35]. However, for such assessments it may be necessary to use the 3D conformational methods. It might be possible to assess this by reviewing the images from those patients treated in the previously published trials.


  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. References
  8. Authors
  • 1
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  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and methods
  5. Results
  6. Discussion
  7. References
  8. Authors

H.S. Bozcuk, MD, Overseas Training Fellow.

R. Ravi, MS, MCh, FRCS, FRCSEd(Gynae), FRCS(Urol), FEBU, Specialist Registrar in Urology.

B. Turner, MSc, DCR, Superintendent Radiographer.

D. Tsetis, MD, Radiology Research Fellow.

J.M. Thomas, MSc, FSS, Medical Statistician.

O. Chan, FRCS, FRCSEd, FRCR, Consultant Radiologist.

R. Reznek, FRCP, FRCR, Professor of Radiology.

W.F. Hendry, MD, ChM, FRCS, Consultant Urologist.

R.T.D. Oliver, MD, FRCP, Sir Maxwell Joseph Professor of Medical Oncology.